When it comes to understanding safety testing and certification, we helped write the book… literally. Rita King, our CEO, participated in the development of safety critical software standards for UL and ANSI, giving us key insight into how certification is achieved. Right now, the immediate challenge is IEC 60601-1.
The 3rd edition of IEC 60601-1 is a major shift from past iterations, changing the way medical devices go through safety testing. There is greater emphasis on risk management documentation and performance in addition to actual laboratory testing, and you now have choices in determining how safety and Essential Performance are maintained. Failure to adapt and conform to these changes will cause costly delays in getting your device to market.
At MethodSense, we recognize that the IEC 60601-1 standard is intended to serve as an aid in the development of your Medical Device Risk Management Program. Our goal is to walk you through the documentation process, providing experienced guidance and interpretation, so you can achieve compliance and, if desired, certification.
- Review the standard you must comply with
- Conduct a gap analysis of your Risk Management Program against ISO 14971
- Update your Risk Management Documentation, Processes and SOPs
- Complete the IEC 60601-1 tables
- Submit your documentation for certification
Receiving this certification ensures:
- Conformity to globally-approved standards
- Reduced risk of liability because of your documented safety standards
- Increased opportunities in the global market
SCHEDULE AN APPOINTMENT WITH ONE OF OUR MEDICAL DEVICE SAFETY CERTIFICATION CONSULTANTS TODAY to ensure your device gets to market quickly and without unnecessary delay.