Biotech Safety Testing Certification
Biotechnology increasingly relies on the integration of electronic and software components for diagnostic or medical devices. With the transition to IEC 60601-1 3rd Edition, the way biotechnology companies manage safety testing is changing significantly. Biotech safety testing requirements now place greater emphasis on risk management documentation and performance. You also have more choices in determining how safety and Essential Performance are maintained.
While there are many advantages to these changes, failure to manage them properly will cause costly delays in getting your device to market.
At MethodSense, we recognize that the IEC 60601-1 3rd Edition requires a robust Product Risk Management Program. Our goal is to walk you through the documentation process, providing expert guidance and interpretation, so you can achieve compliance and, if desired, certification. Together we will:
- Review the standard you must comply with
- Conduct a gap analysis of your Risk Management Program against ISO 14971
- Update your Risk Management Documentation
- Complete the IEC 60601-1 tables
- Submit your documentation for certification
Receiving biotech safety testing certification ensures:
- Conformity to globally-approved standards
- Reduced risk of liability because of your documented safety standards
- Increased opportunities in the global market
