Medical Device Testing Laboratories

JJR Laboratory boasts a strong team of experts in the medical device field and a specialized testing facility. Covering a practical area of 30,000 square meters, the lab includes a biological evaluation laboratory, microbiology laboratory, electrical safety laboratory, electromagnetic compatibility (EMC) laboratory, physical and chemical laboratory, in vitro diagnostic testing room, and medical software testing laboratory. It provides comprehensive testing services throughout the medical device lifecycle, offering critical technical support for developers from R&D to product registration and market launch.

Registration Inspection Agency Services

China’s JJR Laboratory offers testing agency services for manufacturers with finalized products. It assists in selecting suitable national testing institutions, drafting product technical requirements, submitting testing documents, providing advice on test plans, timelines, sample requirements, and rectification suggestions, and following up on testing progress to help advance the inspection process.

Medical Device Testing Standards

U.S. Standards for Medical Device Testing:

- 21 CFR Part 820  

- ISO 13485:2016  

- ISO 14971:2019  

- IEC 60601 Series Standards  

- ASTM F88/F88M  

- ASTM F2475  

- ISO 10993 Series Standards  

EU Standards for Medical Device Testing:

- MDR (EU) 2017/745  

- ISO 13485:2016  

- ISO 14971:2019  

- IEC 60601 Series Standards  

- IEC 62366-1:2015  

- ISO 11607 Series Standards  

- ISO 10993 Series Standards  

- EN 455 Series Standards  

Chinese Standards for Medical Device Testing:

- GB 9706 Series Standards  

- YY/T 0287-2017  

- YY/T 1474-2016  

- YY 0784 Series Standards  

- GB/T 16886 Series Standards  

- YY/T 0681 Series Standards  

Biocompatibility Testing Services (Based on GB/T 16886, ISO 10993 Standards)

1. Cytotoxicity Testing  

2. Irritation and Skin Sensitization Testing  

3. Hemolysis Testing  

4. Pyrogen Testing  

5. Acute Systemic Toxicity Testing  

6. Subacute/Subchronic/Chronic Systemic Toxicity Testing  

7. Subcutaneous/Muscle Implantation Testing  

8. In Vivo Degradation Testing  

9. Genotoxicity Testing  

Animal Testing Research

1. Animal Efficacy Studies  

2. Animal Pathology and Toxicology Research  

Physical and Chemical Characterization of Medical Devices

1. Material Characterization  

2. Chemical Routine Testing  

3. Extractables and Leachables Studies  

4. Chemical Equivalence Research  

5. Product Function and Performance Research  

6. Stability Studies of Medical Devices and Packaging  

7. Biodegradability Research  

8. Compatibility Studies Between Medical Devices and Drugs  

9. MRI Compatibility Studies  

Microbiological and Environmental Testing for Medical Devices

1. Microbial Limits and Sterility Testing  

2. Bacterial Endotoxin Testing  

3. GMP Production Environment Testing for Medical Devices  

4. Purified Water Testing  

5. Testing of Biological Safety Cabinets and Clean Benches  

6. Bacterial Reverse Mutation Test  

7. Microbial Barrier and Antibacterial Testing  

Sterilization Control and Validation for Medical Devices

1. Cleaning, Disinfection, and Sterilization Validation  

2. Sterilization and Expiry Date Validation  

Aging Validation for Medical Devices

1. Shelf-Life Validation  

2. Transport Stability Studies for Medical Devices  

3. Shelf-Life Studies of Packaging Materials  

Electrical Safety and EMC Testing for Active Medical Devices

1. Safety Testing for Medical Electrical Equipment (GB 9706.1 Series Standards)  

2. Safety Testing for Laboratory and IVD Equipment (GB 4793 Series Standards)  

3. EMC Testing (YY 9706.102, GB/T 18268.1, GB/T 18268.26)  

4. Simulated Environmental and Mechanical Testing  

5. Pre-Inspection and Rectification Validation Testing  

6. Usability Research  

7. Risk Analysis Research  

8. Post-Market Performance and Safety Assessment  

Medical Software Testing

1. Testing for Standalone Software as a Medical Device (SaMD) and Software Components (SiMD)  

2. Cybersecurity Testing for Medical Devices  

3. Quality Evaluation for Health Software  

4. Individual Software Performance Testing  

5. Usability Testing for Medical Software  

6. Risk Management During Design, Software Development, Testing Outsourcing, and Consultation  

7. Risk-Related Consulting for Programmable Medical Electrical Systems (PEMS)  

8. Acceptance Testing for Technological Projects  

9. Software Product Registration Testing  

In Vitro Diagnostic Products (IVD)

1. R&D and Design Services for IVD Products  

2. Performance Testing for IVD Products  

China JJR Laboratory is accredited with CMA, CNAS, GLP, GCP, and ISO/IEC 17025. It is also authorized by FDA and CE organizations. We welcome your submissions for testing.

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