Review of Process Standards Risk Management Usability PEMS and SoftwareBy Intertek
Regardless of what product development stage you are in, Intertek can help you speed-up your time to market. As medical device manufacturing companies work to embrace the sometimes complex factory production control and extended documentation requirements that the IEC 60601-1 (3rd edition) standard brings, on top of traditional testing.
Many organisations have found that despite their preparations the compliance process is longer than it was against the 2nd edition. This is because the 3rd Edition of IEC 60601-1 represents a shift in philosophy from the 2nd Edition, introducing the requirements of Process Standards (Risk Management, Usability, PEMS and Software).
By engaging Intertek to review your quality and risk management documentation early in development, you can avoid many common compliance failures later on. This will reduce the overall time it takes to complete your compliance programme and will get you to market faster. Download our paper to find out more.