cyclopsio

Electrical Safety Certifications for Medical Devices are a Confusing Mess

For the uninitiated, electrical safety certification of medical devices is a dazzling cornucopia of intermeshed standards and marks. It takes some in depth studying to disentangle all the various aspects. But let’s give it a go! NRTL’s, Standards, Marks, and Regulatory Agencies What makes this topic especially confusing is that there are multiple aspects toContinue reading “Electrical Safety Certifications for Medical Devices are a Confusing Mess”

Scope of Design Control

Many medical device companies struggle to understand the scope of design control, with the result being an ineffectual application of wasted effort. To maintain a lean and agile development process, it’s crucial to have a clear understanding of exactly what ISO 14971 requires. I’ve seen misguided project managers insist on detailed record keeping of earlyContinue reading “Scope of Design Control”

Referenced Documents List = TIME SINK

Don’t waste your time on extensive referenced documents lists. Nobody cares! I often see medical device companies include long, long lists of every DHF document in their documentation front matter. You are wasting your time! The FDA doesn’t care about this. EU MDR doesn’t require this. Your quality department shouldn’t care about this. What I’veContinue reading “Referenced Documents List = TIME SINK”