60601-1 3rd Edition Transition

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 than actual laboratory testing, and you now have choices in determining how safety and Essential Performance are maintained. Failure to implement 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 Med Device Risk Management Program. Our goal is to walk you through the process, providing expert guidance and interpretation, so you can achieve 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 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 TODAY to ensure your device gets to market quickly and without unnecessary delay.