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Comprehensive Testing Services for Medical Device Registration

Partner with Us for Internationally Recognized Testing

 

As a trusted regulatory consulting firm with established partnerships across EU, US, China, and Brazil, we offer a full spectrum of testing services for medical devices at different stages—from prototype development to final product registration. Our testing solutions ensure compliance with regulatory standards across multiple markets, reducing waiting times, costs, and complexity for manufacturers.

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Testing Services for International Markets

 

For the European Market (EU MDR & UKCA)

  • Battery Testing (available in the EU and with faster processing in China)

  • RoHS & REACH Testing (for environmental compliance)

  • RED Testing (for radio equipment and wireless medical devices)

  • Shelf-Life & Aging Studies (to verify long-term stability and performance)

  • Cybersecurity Testing (IEC TR 60601-4-5, IEC 81001-5-1, NIST 8529a, NIST 8425, etc.)

  • Biocompatibility & Sterilization Validation (ISO 10993 series & ISO 11135/ISO 17665)

 

For the US Market (FDA & FCC Compliance)

  • NRTL Testing (for electrical safety, required for UL-listed products)

  • FCC Testing (for wireless medical devices and radio frequency emissions)

  • 510(k) Performance & Bench Testing (for substantial equivalence demonstration)

 

For the Chinese Market (NMPA Requirements)

  • Chinese Type Testing (mandatory for Class II & III devices)

  • Electrical Safety & EMC Testing (based on GB/T and YY standards)

 

For the Brazilian Market (ANVISA & INMETRO)

  • INMETRO Testing & Certification (for electrical & non-electrical medical devices)

  • Biological & Chemical Compatibility Studies (for sterilized products and implants)

 

Beyond Medical Device Testing

  • Chinese CCC Testing (for non-medical electronic products entering China)

  • Material & Component Testing (to validate early-stage product development and component selection for startups & innovators)

 

Multi-Center Study & Prototype Testing

 

For startups and established medical device manufacturers, we offer comprehensive testing solutions that support regulatory approval across multiple markets:

✅ Prototype Testing & Optimization – Validate early-stage concepts and refine designs before full-scale production.
✅ Feasibility & Preclinical Testing – Ensure compliance with global regulatory expectations from the outset.
✅ Multi-Center Performance & Clinical Studies – Conduct studies across different regions to support simultaneous submissions in multiple markets (EU MDR, FDA, NMPA, etc.).
✅ Regulatory-Aligned Study Design – Develop harmonized clinical protocols that align with the requirements of diverse regulatory authorities.
✅ Agile Testing Plans – Adapt test requirements dynamically based on iterative R&D processes and market-specific demands.

 

Why Choose Us?

🔹 Shorter Lead Times – We scan multiple labs based on price, expertise & availability
🔹 Professional Test Plan Assessment – Reduce regulatory risks before testing
🔹 On-Site Troubleshooting – Support throughout the 2-3 month testing process
🔹 Registerable Reports – Generate compliant test reports valid for multi-market registration
🔹 Agile Design Change Support – Ensure continuous compliance in product lifecycle

Chinese type testing

One third of Chinese registration of medical device is at local type testing where manufacturer has to send product to test as per Chinese standards.

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Testing beyond and for registration 

Testing of finished medical device is key for safety and performance. You should know when and how to test conform to international standards.

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