Overview of Global Orthopedic Robot Products and Technologies

For more technical content, please visit: Medical Device R&D Column

http://med.anytesting.com

Source: Medical Device Home

The orthopedic medical device industry is a high-tech industry that is multidisciplinary, knowledge-intensive, and capital-intensive. The products integrate various disciplines and technologies such as medicine, materials science, biomechanics, testing analysis, surface technology, and mechanical manufacturing. From a treatment perspective, orthopedic medical devices can be categorized into trauma, spine, joint, and foot and ankle devices. Trauma devices are the most common and fundamental, followed by spine and joint devices.

According to statistics, the domestic orthopedic device market is nearly 50 billion in market size, with a large proportion of joint devices. The market shares of joint and spine products are 44.75% and 23.39%, respectively. As the population ages, more elderly people require joint replacements. Industry consolidation is also intensifying, with foreign capital continuously acquiring domestic companies, and international companies merging with each other, leading to fierce competition. Currently, 90% of the global market is dominated by the top 10 foreign companies. The global orthopedic market has provided certain insights for China, and domestic companies have also increased their investments in the joint market in recent years. The following overview of orthopedic medical device companies can provide some insight, for reference only.

Let’s take a look at representative foreign companies,in recent years, personalized, precise, and minimally invasive treatment methods have become important development directions for orthopedic surgery,the application of surgical robots, medical imaging and other technologies has intensified competition in the orthopedic surgical robot field. Companies laying out orthopedic surgical robots abroad include Stryker, Medtronic, and Smith & Nephew, which are accelerating their penetration into the orthopedic medical device market.

1. Johnson & Johnson

Johnson & Johnson is a manufacturer of healthcare products, medical devices, and pharmaceuticals, established in 1886, headquartered in New Jersey, USA. It consists of over 250 subsidiaries globally, with products sold in over 170 countries and regions. On January 12, 2021, the Hurun Global 500 report was released, ranking Johnson & Johnson 14th with a value of 256 billion RMB. Johnson & Johnson focuses more on the innovation of orthopedic surgical robot platforms, announcing a change in its previous plans for the orthopedic surgical robot platform during the second-quarter earnings call, seeking US market approval for its general surgical robot platform through the 510(k) pathway. Johnson & Johnson has made it clear that clinical research on this platform will begin in the second half of 2022. Recently, the VELYS™ was approved for market, marking a significant step forward for Johnson & Johnson in the orthopedic robot field.

VELYS™ System

This system is the first in its category with a portable design that can be placed beside the surgical table, supporting plug-and-play integration into any operating room environment. Its system has excellent planning capabilities, optimizes the surgical process for doctors, and adapts to their surgical habits. It can assist surgeons in accurately removing bone during total knee arthroplasty, aligning and positioning the implant relative to soft tissue without the need for preoperative imaging. Surgeons can perform procedures without disposable instruments, significantly reducing surgical costs.

2. Medtronic

In December 2018, Medtronic completed the acquisition of Mazor Robotics and its spinal robotic-assisted surgical platform for $1.7 billion. A month later, Medtronic launched the Mazor X Stealth robotic-assisted spinal surgery platform in the US, which is expected to contribute to its neurosurgery business and generate demand for spinal implants.

Prestige LP™ cervical disc is the first single and two-level joint replacement device approved by the US FDA, reporting 10 years of IDE study data.Prestige LP titanium ceramic composite material is free of nickel, cobalt, or chromium, and allows for clear MRI imaging of the spine. Prestige LP uses streamlined instruments for smooth, repeatable workflows.

MAZOR X stealth robot navigation platform combines advanced surgical planning software with 15 years of MAZOR robot navigation experience and 25 years of stealth™ navigation experience.

3. Stryker

Stryker is the largest orthopedic medical device company globally, with its Mako joint surgery robot system widely used worldwide, holding a global market share of 9%, and has been certified by CFDA, making it the only orthopedic surgical robot in China capable of performing joint replacements. The developed Mako smart orthopedic robot has also conducted the first surgery in China.In December 2020, the National Clinical Medical Research Center for Orthopedics and Sports Rehabilitation completed the first domestic intelligent orthopedic robot-assisted total biological knee joint replacement surgery using this product, accurately completing the highly complex biological prosthesis insertion.

Mako Surgical Robot

4. Zimmer Biomet

Zimmer Biomet is a medical device company that develops and manufactures correction products such as dental and spinal implants, approved in October 2018 for personalized knee joint implants with custom components to match each patient’s anatomy; in early 2018, the company’s Rosa knee robot-assisted total knee replacement surgery platform was approved, followed by the Rosa One robotic spinal system.

Knee Joint Featured Products:NexGen Gender Solutions™LPS-high flexion posterior artificial knee can create user-matched solutions for first-time or revision total knee arthroplasty through the NexGen system. A complete set of parts, sizes, and fixation method options can be designed to optimize joint reconstruction and stability for users.

Main Shoulder Joint Products

Main Hip Joint Products

Main Knee Joint Products

5. Smith & Nephew

Smith & Nephew is an international multinational medical company with a history of 150 years, headquartered in London, UK, leading the world in four fields: orthopedic joint reconstruction, advanced wound management, sports medicine, and trauma, occupying the number one position globally in sports medicine and second in orthopedic trauma. Its joint products include knee, hip, and shoulder joints. Some star products in the joint category include: GenesisII total knee system (launched in 1996, with over 750,000 implants), Oxinium black crystal femoral condyle (a patented product unique to Smith & Nephew, awarded the highest international material award ASM in 2005), Journey II XR knee replacement system (new product in 2017).

6. NuVasive

NuVasive, based in San Diego, California, is an innovative medical device company dedicated to developing disruptive minimally invasive surgical products and cervical replacement devices, making it the third-largest spinal medical device company globally. In early February 2018, media reported that Smith & Nephew planned to acquire NuVasive, with a total deal amount exceeding $3 billion.

NuVasive launched the C360 spinal product portfolio, including the commercially launched anterior cervical plate (ACP) system, the thinnest 1.6 mm plate on the market.

7. Think Surgical

Think Surgical, headquartered in Fremont, California, raised a round of funding worth $134 million in March 2019. The FDA approved the second-generation Think Surgical’s TSolution One total knee application 510(k) license. TSolution One is an active total knee replacement robot that achieves fully automated bone preparation and provides surgeons with multiple implant options.

According to Think Surgical, the new version of the system features include an enhanced preoperative planning user interface, quick tool interchange, improved surgeon accessories, and advanced bone model generation.

Think Surgical’s TSolution One robotic-assisted surgical system

China’s orthopedic surgical robots started relatively late, with several domestic companies laying out robots,most in early development, such as Tianzhihang, MicroPort, Weigao Group, etc. Among them, listed companies like Weigao Group have expanded their orthopedic robot business in recent years. The development of orthopedic surgical robots is relatively earlier, with Tianzhihang, which focuses on orthopedic surgical robots, being the leading domestic company in this field. Rosenbot, Santan Medical, and Xinjunte, founded in recent years, are still in the nurturing period.

1. MicroPort

In 2020, the domestic market for total knee replacement robots achieved remarkable results. The orthopedic surgical navigation positioning system developed by MicroPort, Honghu®Skywalker®, and the orthopedic surgical navigation positioning system (TiRobot Recon) developed by Tianzhihang passed the National Medical Products Administration (NMPA) special review application for innovative medical devices in May and November, respectively.

In May 2020, MicroPort (Shanghai) Medical Robotics Co., Ltd. announced that its independently developed Honghu®Skywalker® orthopedic surgical navigation positioning system passed the National Medical Products Administration (NMPA) special review application, entering the special review procedure “green channel.”

2. Weigao Group

In 2008, supported by the National Natural Science Foundation of China and the major research programs of the National Science and Technology Plan, Central South University, Tianjin University, and Shandong Weigao Group began a joint research project named “Miaoshou” for a new type of porous laparoscopic surgical robot. After years of unremitting efforts, the Chinese “Miaoshou” has successfully been applied in clinical surgeries and is about to enter industrialization. The Miaoshou robot mainly targets laparoscopic minimally invasive surgeries, assisting surgeons in various procedures, applicable in thoracic surgery, urology, gynecology, and more.

Since it is produced and sold in China, the internal cost of the system’s parts is lower, reducing the price. Compared to the surgical costs abroad, which can reach 60,000 to 70,000, the operational cost of the Miaoshou robot is only half of that, making it more suitable for the Chinese market, and also suitable for widespread promotion, breaking the foreign technology monopoly.

3. Tianzhihang

Tianzhihang is the first domestic company to obtain the CFDA Class III medical device registration certificate for the “orthopedic robot navigation positioning system,” and is also the only “international original” product in innovative medical devices in 2018. Tianzhihang’s third-generation surgical navigation system “Tianji” obtained the CFDA Class III registration certificate in November 2016, making it the first domestic and fifth globally to obtain a medical device robot registration license.

On February 10, NMPA published information about the medical device approval certificate (production approval) waiting to be collected on its website.It is reported that the orthopedic surgical navigation positioning system (Tianji®2.0) produced by Beijing Tianzhihang Medical Technology Co., Ltd. (hereinafter referred to as “Tianzhihang,” stock code: 688277) has been approved for market, with registration number: National Medical Device Registration No. 20213010095.

Orthopedic surgical navigation positioning system (Tianji®2.0)

4. Jianjia Robot

The first joint replacement surgical robot product “ARTHROBOT” from Jianjia Robot has entered the clinical trial phase and is expected to become the first domestic joint replacement surgical robot to obtain NMPA registration. The core technical team of Jianjia Robot comes from the Tsinghua University National Laboratory of Intelligent and Systems, achieving innovation and research and development in key technologies, while closely aligning with the needs of doctors in clinical applications, solving the pain points of traditional artificial joint replacement surgeries. In April 2020, it was reported that Hangzhou Jianjia Robot Co., Ltd. (hereinafter referred to as “Jianjia Robot”), dedicated to the research and production of intelligent orthopedic surgical robots, completed several tens of millions in Series A financing from BV Baidu Venture Capital. In early 2019, Jianjia Robot received angel round investment from PwC Capital and Kefa Capital.

In terms of products, Jianjia’s independently developed surgical robot provides comprehensive solutions for orthopedic surgery, achieving full process coverage of “preoperative, intraoperative, and postoperative.” Preoperatively, intelligent preoperative planning software can process data on the terminal and interact with doctors to design surgical plans, significantly shortening preoperative preparation time with unique calibration automation and registration algorithms; intraoperatively, robot operation control, gravity compensation, and multi-mode switching functions assist doctors in precise operations, simplifying surgical steps and providing a better tactile experience; postoperatively, relying on a real-time postoperative evaluation system, doctors can quickly and comprehensively understand the surgical implementation effect.

5. Santan Medical

Santan Medical, established in 2011, is a high-tech medical device research and development enterprise integrating independent innovation research and development, standardized production, professional sales, and quality medical services. Santan Medical’s product matrix includes the “Intelli-Micro Eye®” surgical guidance and feedback system and series products, “透视眼” fracture reduction auxiliary system, applicable to multiple departments such as spine, trauma, joints, emergency, etc.

The “Intelli-Micro Eye” laser linear navigation system adopts the “X-ray tracking method,” based on the common C-arm machine in operating rooms, consisting of main components such as a fixed frame, laser driver, microcomputer host, etc. Compared to traditional “GPS positioning navigation technology,” this system uses linear positioning navigation technology, characterized by simplicity of operation, high accuracy, and cost-effectiveness, with the laser-displayed surgical path being more intuitive than virtual navigation.

“Intelli-Micro Eye” surgical guidance and feedback system

6. Rosenbot

Rosenbot, established in 2017, is the product of close integration between Beihang University and Beijing Jishuitan Hospital in medical engineering, dedicated to providing intelligent solutions for medical institutions and driving the transformation of medical models through technological innovation. The company is committed to creating a new generation of intelligent orthopedic surgical robot systems with fracture reduction functions, pioneering real-time intraoperative 3D navigation, assisted fracture reduction operations, and automatic surgical planning, achieving intelligent surgical operations throughout the entire process from fracture closure reduction to minimally invasive fixation, meeting the urgent clinical treatment needs.

A new generation orthopedic surgical robot system with fracture reduction functions

In October 2020, intelligent surgical robot developer Rosenbot (ROSSUM ROBOT) completed several tens of millions in Pre-A+ round financing, with the investor being Yahui Investment. This round of financing is mainly used to promote further research and clinical trials of the company’s intelligent orthopedic surgical robot. In early 2020, Rosenbot completed several tens of millions in pre-A round financing.

7. Xinjunte

Xinjunte, established in 2015, is a high-tech enterprise focusing on high-end intelligent medical device manufacturing and orthopedic artificial intelligence applications. According to public information, Xinjunte currently has an intelligent orthopedic minimally invasive surgical system with complete independent intellectual property rights. The main structure of this system consists of a doctor workstation and orthopedic surgical robot ORTHBOT.

ORTHBOT is Xinjunte’s flagship product, integrating preoperative planning, intraoperative navigation, and terminal execution into a multi-functional surgical system. It successfully completed clinical trials in 2018. It uses surgical planning and dedicated robotic arms to assist doctors in completing a large number of complex, high-difficulty, and high-risk surgical operations, ensuring precision and efficiency while safeguarding surgical safety.

8. Kando Robot

Suzhou Kando Robot Co., Ltd. was established on January 7, 2014. In early and mid 2019, the company completed the world’s first remote robotic surgery experiment based on 5G networks and the world’s first multi-point collaborative 5G remote robotic surgery experiment, with products passing special approval for innovative medical devices. Its multi-minimally invasive surgical robot system is a multi-arm laparoscopic minimally invasive surgical robot product, including a doctor control console, multi-arm robot system, multi-degree-of-freedom surgical micro-instruments, and high-definition 3D visual systems, among other products and related auxiliary equipment.

According to General Manager Sun Yuning, the robot’s robotic arms have 11 degrees of freedom. Among them, two instrument arms can be equipped with 15-20 types of end surgical instruments, including scissors and electric hooks. The entire system adopts a “master-slave” operation mode, allowing doctors to observe the lesion position in three dimensions. Through the operation of the “master hand” control lever, the “slave hand” robotic arm can accurately and quickly move the surgical instruments, effectively overcoming the physiological limits of human hands and eyes, enhancing the range and dexterity of surgical operations, and achieving precise robotic intraluminal surgery.

Currently, the development of the medical robot industry has only been around thirty years, while the orthopedic market is still in its early stages. The domestic orthopedic device market is still less than 50 billion in market size, and the share of orthopedic robots is currently less than 2%, indicating significant potential for market growth. With the future development of surgical robots, medical imaging, and other manufacturing technologies, orthopedic surgical robots will inevitably see widespread application in minimally invasive orthopedic fields. In recent years, while China has made some progress in orthopedic robots, there is still a significant gap compared to foreign countries in key technologies and core component development, as well as market scale. However, it is encouraging that companies with independent intellectual property rights in orthopedic robot technology continue to emerge.

Medical device R&D experiments, technical training, registration agency

National customer service phone: 4008180021

Massive medical device R&D materials available for download:

Some directories

1. (Chinese version) Medical Device R&D Manual – Second Edition – Part Two: Processes in Medical Device R&D

2. (Chinese version) Medical Device R&D Manual – Second Edition – Part Three: Methods in Medical Device R&D

3. (Chinese version) Medical Device R&D Manual – Second Edition – Part Four: Interviews and Highlights of R&D Entrepreneurs

4. (Chinese version) Medical Device R&D Manual – Second Edition – Part One: Materials in Medical Device R&D

5. DFMA Design for Manufacturing and Assembly – English version Part 11-12 (98 pages)

6. DFMA Design for Manufacturing and Assembly – English version Part 1-2 (111 pages)

7. DFMA Design for Manufacturing and Assembly – English version Part 13-14 (113 pages)

8. DFMA Design for Manufacturing and Assembly – English version Part 3-4 (112 pages)

9. DFMA Design for Manufacturing and Assembly – English version Part 5-6 (76 pages)

10. DFMA Design for Manufacturing and Assembly – English version Part 7-8 (111 pages)

11. DFMA Design for Manufacturing and Assembly – English version Part 9-10 (86 pages)

12. [E-book] Guide to Thermal Design Reliability of Electronic Devices by Xu Weixin (193 pages)

13. [E-book] Product Design for Manufacturing and Assembly (567 pages) Chinese version

14. [E-book] Clinical Trial Design, Execution, and Management of Medical Devices (296 pages)

15. 2020 China Desensitization Product R&D and Industry Research Report (16 pages)

16. 570 Common Standards for Medical Device R&D Summary.doc (40 pages)

17. DFMA Design for Manufacturing and Assembly.ppt (30 pages)

18. DFMEA Development and Production.ppt (53 pages)

19. DOE Experimental Design and Case Operation Training PPT

20. DOE Experimental Design Template.xls

21. ESD Protection Design and Handling Training PPT(26 pages)

22. FDA Release of Tablet Development QBD Case (92 pages)

23. FDA Medical Device Manufacturer Design Control Guidelines (28 pages)

24. GB 9706.1-2020 Application in Medical Device R&D Process Training PPT (61 pages)

25. GMP Independent Software Quality System Explanation Design Development (Part 1) PPT (22 pages)

26. IEC60601-1 Medical Device Safety Standard Principles and Design Training Materials.ppt (116 pages)

27. IEC61215.2005 Ground-mounted Crystalline Silicon Photovoltaic Modules – Design Verification and Certification GB/T 9535 (Chinese version, 34 pages)

28. IND, NDA Dissolution Method Development Confirmation Training PPT (50 pages)

29. LC-MS Liquid Chromatography-Mass Spectrometry Method Development

30. PCBA Circuit Board Level Reliability Design (Single Board, Components).ppt (25 pages)

31. PCB Design Basic Process Requirements (5 pages)

32. TI Power Design Experience Collection (98 pages)

33. TI Design: Body Composition Function and BLE Connected Weight Scale Reference Design

34. USP 1092 Dissolution Test Development and Validation [Bilingual Version].doc (54 pages)

35. Ankai Bus R&D Quality Management System Training Materials.ppt (60 pages)

36. Design Development Failure Mode Analysis Case of Safety Blood Collection Needle.doc (3 pages)

37. Sheet Metal Structure Design Process Manual (36 pages)

38. Portable Heart Rate Collection System Design.doc(40 pages)

39. Design and Development Procedures for Products and Services (including forms).doc (21 pages)

40. Product Structure Design Guidelines – Draft Angle.doc (3 pages)

41. Product Structure Design Guidelines – Holes.doc (4 pages)

42. Product Structure Design Guidelines – Tolerances.doc (4 pages)

43. Product Structure Design Guidelines – Snap Joints.doc (6 pages)

44. Product Development Process PPT (12 pages)

45. Product R&D Management System (17 pages)

46. Testing Training in the Product Development Process PPT

47. Defibrillator R&D and Industry Research Report (34 pages)

48. Innovative Drug R&D Process Training.ppt

49. Research on Supplier Management in the Development Process of Large Medical Equipment – Taking GE Medical as an Example.doc (52 pages)

50. Electromagnetic Compatibility Design Training Materials.ppt (83 pages)

51. Electronic System Reliability Design Training PPT (129 pages)

52. Trends in the Design of Electronic Blood Pressure Monitors.ppt

53. Design Guidelines for Mistake-Proofing Training Materials.ppt (34 pages)

54. Template Case for Generic Drug Development

55. Overview of Generic Drug R&D Project Management System Training PPT (37 pages)

56. Tooling Fixture Design Training Materials PPT (80 pages)

57. Selection of Sample Size for Design Verification and Confirmation Based on Risk Assessment (6 pages)

58. Information on In Vitro Diagnostic Reagent Product R&D, Registration, and Evaluation – Part 1 (24 pages)

59. Information on In Vitro Diagnostic Reagent Product R&D, Registration, and Evaluation – Part 2 (9 pages)

60. Huawei EMC Design Guidelines (85 pages)

61. Huawei PCB Design Specifications (21 pages)

62. Huawei Electromagnetic Compatibility Structural Design Specifications (56 pages)

63. Huawei Electromagnetic Compatibility Structural Design Specifications V20 (133 pages)

64. Huawei Protection Circuit Design Specifications (60 pages)

65. Huawei Process Reliability Design Methods and Practices.ppt (71 pages)

66. Huawei Thermal Design Training PPT (92 pages)

67. Huawei R&D Department – Product Structure Design and Mould Development Process (6 pages)

68. Huawei R&D Requirements and Design Engineering Document Writing Training (including templates).ppt (90 pages)

69. Chemical Raw Material Drug Process R&D and Process Validation.ppt

70. Mechanical Reliability Design Training PPT (240 pages)

71. Mechanical Design Terminology Chinese-English Comparison (24 pages)

72. Research on Performance Evaluation Model for R&D Team Based on Product Development Process (3 pages)

73. Research and Design of Body Emission Coil Based on Magnetic Resonance Imaging.caj (67 pages)

74. Development Strategies for Drug Impurity Research Based on Risk Assessment & Common Problems Analysis in Impurity Research.ppt (76 pages)

75. Design and Implementation of Ultrasonic Atomizer Based on Embedded Systems.caj (61 pages)

76. Emergency R&D Management Process

77. Switching Power Supply Design A to Z (523 pages)

78. Lightning Surge Protection Design Technology Training Materials.ppt (64 pages)

79. Medtronic Puritan Bennett 560 (PB 560) Ventilator Complete Design Data (1)

80. Medtronic Puritan Bennett 560 (PB 560) Ventilator Complete Design Data (2)

81. Design Guidelines for Assembly Training Materials.ppt (81 pages)

82. Mould Design and Processing Technology.doc (31 pages)

83. Chery Automobile Whole Vehicle Development Process.ppt

84. Automobile Parts Development Process (3 pages)

85. Discussion on the Application of HALT Testing in Reliability Design

86. Discussion on the Necessity of Reliability Testing in the Verification of Measurement and Control Device Product Design

87. Discussion on the Design and Development Transition of Medical Devices

88. Balloon Pressure Pump Design Points – Interpretation of YY/T0450.3-2016 Standard.doc (5 pages)

89. The Situation and Opportunities Facing New Drug R&D of Traditional Chinese Medicine in the Context of Global R&D (6 pages)

90. Complete Medical Device Development Documents

91. Complete Medical Device Design and Development Materials (modifiable templates).doc (95 pages)

92. Thermoplastic Elastomer Formulation Design Skills (6 pages)

93. Current Status and Development of Artificial Heart Valve R&D (4 pages)

94. How to Manage Drug R&D Records and Data.doc (35 pages)

95. How to Conduct Raw Material Drug R&D.ppt (77 pages)

96. How to Design Effective Preclinical Animal Efficacy Experiments for Implantable Medical Devices.ppt (25 pages)

97. Software Design and Development Control Procedures.doc(10 pages)

98. Three-Way Valve and PC Embedded Bonding Design Plan.doc (14 pages)

99. Design and Development Verification Sharing

100. Design and Development Verification Stage

101. Design Development Form Template (36 pages)

102. Design Potential Failure Modes and Effects Analysis (DFMEA)

103. Classic Case Analysis of Design Failure Analysis DFMEA.ppt (41 pages)

104. Research and Development of Biological and Medical Materials from Development to Market.ppt (10 pages)

105. Application of Experimental Design in Medical Device Production Process Confirmation (8 pages)

106. Design of Externally Charged Implantable Artificial Heart Pacemaker (4 pages)

107. Key Points and Statistical Analysis Methods for Designing In Vitro Diagnostic Reagent Plans Training PPT (88 pages)

108. Training PPT for Design and Development of In Vitro Diagnostic Reagents to Market (191 pages)

109. Design Requirements for Coating Dust High-Temperature Ovens on Ducts and Heating

110. Design and Preparation of External Ointments Training Materials PPT (35 pages)

111. Design and Development of Sterile Medical Device Packaging and Experimental Training PPT (74 pages)

112. Design Training PPT for Sterile Medical Device Packaging (35 pages)

113. Guidelines for Technical Documents and Design Documents of Passive Medical Devices (25 pages)

114. Principles of Modern Medical Electronic Instrument Design and Training Materials.ppt (58 pages)

115. Analysis and Design Ideas of ECG Monitor Defibrillation Testing (3 pages)

116. New Product Design and Development Process and Output Documents (4 pages)

117. Medical Device Design and Development Under New Regulations.ppt

118. Design and Prototype Development of New Dental X-ray Machines (3 pages)

119. Key Points of Pharmacological Toxicological Research in New Drug R&D Training Materials.ppt (46 pages)

120. New Drug R&D and Design Process.ppt (29 pages)

121. Design, Production, and Testing of Vascular Stents.ppt

122. Research Progress of Blood Dialyzer Membrane Materials and Prospects (4 pages)

123. R&D Department Operation Guideline Manual (164 pages)

124. R&D Management Process Specification.ppt

125. Performance Evaluation of R&D Personnel.ppt (136 pages)

126. R&D Project Management – IPD Process Management.ppt

127. R&D Project Management Tools and Templates.ppt (134 pages)

128. R&D Project Completion Management Method.doc (3 items)

129. R&D Quality Management Basic Training PPT (24 pages)

130. R&D Quality Management Training PPT (120 pages)

131. Types of Liquid Chromatography Columns and Method Development Training Materials.ppt (42 pages)

132. A Clear Process Flow Chart for Design and Development

133. A Diagram to Understand the Design and Development Requirements of Medical Device Systems

134. Discussion on Medical Device Packaging Design (4 pages)

135. Summary of Medical Device Product Design and Development Process, Documents, and Forms (56 pages)

136. Compliance Assurance Training for Medical Device Product Development Process PPT

137. Division of Medical Device Product Development Stages and Major Tasks of Each Department.doc

138. Trends in Medical Device Product Design Development (8 pages)

139. Medical Device Product Design Development Plan.doc (2 pages)

140. Sample Size Design for Medical Device Sampling Inspection Training Materials PPT

141. The Three Major Barriers Faced by Medical Devices from R&D to Market PPT (45 pages)

142. Design and Development of Medical Devices and Technical Document Checklist, Cases

143. Analysis of Medical Device Design Principles (8 pages)

144. Common Problems and Design Rectification Training PPT for Medical Device Electromagnetic Compatibility Testing (131 pages)

145. Design Training PPT for Animal Experiment Research in Medical Devices (19 pages)

146. Independent Software Design and Development Site Inspection Training PPT for Medical Devices (22 pages)

147. Medical Device Development and Registration Flowchart (2 pages)

148. Medical Device Project Approval and Design Development Plan Document Templates (11 documents).doc

149. Principles and Design Methods for Developing Clinical Trial Protocols for Medical Devices (3 pages)

150. Key Points for Designing Clinical Trial Protocols for Medical Devices Training PPT (24 pages)

151. Discussion on Key Points for Designing Clinical Trial Protocols for Medical Devices (6 pages)

152. Common Problems and Design Optimization Training PPT for Sterilization Packaging of Medical Devices (23 pages)

153. Design of Capability Verification Plans for Medical Devices (5 pages)

154. Considerations for Medical Device Software User Interface Design.doc(3 pages)

155. Medical Device Design Development Management Training Courseware.ppt(40 pages)

156. Training PPT for Control of Medical Device Design Development Process

157. Checklist for Medical Device Design Development Technical Documents (95 pages)

158. Medical Device Design Development Control Procedures.doc (8 pages)

159. Medical Device Design Transition Procedures Document.doc (3 pages)

160. Medical Device Design Transition Report Template.doc (2 pages)

161. Medical Device Design Transition Training Materials.ppt (15 pages)

162. Design Discussion on the Layout of Sterile Testing Rooms for Medical Device Manufacturing.doc (3 pages)

163. Interpretation of Medical Device Production Quality Management System Regulations – Design Training PPT(24 pages)

164. Medical Device Project Development Process Flowchart(3 pages)

165. Medical Device New Product Development Management Process.doc (3 pages)

166. Medical Device New Product Development Management System.doc (7 pages)

167. Criteria for New Product Development Selection Table.xls

168. Medical Device New Product Design Development Process and Output Documents.doc (4 pages)

169. Three Levels of Medical Device R&D.ppt

170. Required DMR and DHF Documents for Each Stage of Medical Device R&D.xlsx (4 pages)

171. Medical Device R&D Tools

172. Comparison of National, Provincial, and Municipal Declaration Requirements for Medical Device R&D Institutions.xls

173. Complete Cycle Document Directory for Medical Device R&D to Market.doc (3 pages)

174. Medical Device R&D Design (141 pages)

175. Medical Device R&D Manual Second Edition – Part Two (Chinese version)

176. Medical Device R&D Manual – Second Edition – Part One (Chinese version)

177. Medical Device R&D Document Management Regulations.doc (9 pages)

178. Design Control Guidelines for Medical Device Manufacturers (53 pages)

179. Design Qualification (DQ) Verification Plan Template.doc (15 pages)

180. Medical Device R&D Stainless Steel Materials & Special Alloy Materials.ppt (15 pages)

181. Pharmaceutical R&D Analysis Method Validation Process Training PPT

182. Common Problems and Specifications of Original Records in Pharmaceutical R&D PPT

183. Thoughts on Electromagnetic Compatibility Testing and Design of Medical Electrical Equipment (8 pages)

184. Progress of Medical Balloon R&D (9 pages)

185. Design, Preparation, and Testing of Medical Hydrogels.ppt (44 pages)

186. Current Status and Application of Silver-based Antibacterial Materials (3 pages)

187. Hardware Reliability Testing Design (5 pages)

188. Research on Malignant Ventricular Arrhythmia Discrimination Methods and System Control Software Design for AED (64 pages)

189. Transparent SOUP and COTS Software for Medical Device Development (10 pages)

190. Raw Material Drug Process R&D and Control.ppt (90 pages)

191. Application of Orthogonal Experimental Design in Medical Device Design and Development Process (4 pages)

192. Stent Design

193. Regulatory Requirements for the Design and Development of Implantable Medical Device Products Training Materials.ppt (26 pages)

194. Basic Training Materials for Treatment Instruments Design.ppt (60 pages)

195. Draft for Development of Intelligent Nursing Machine Products.ppt(24 pages)

196. Design Guidelines for Injection Moulded Parts Wall Thickness.doc (7 pages)

197. Final Sterilization Medical Device Packaging Plan, Design Points and Risk Assessment Training Materials.ppt (31 pages)

It is recommended to use a computer to search for the material name to download:

Download link

http://www.anytesting.com/data/c-14.html

[Click to Download]Latest Medical Device Technology Materials