Medical  Device  &  QA  Consultancy

MEDICAL DEVICE DIRECTIVE CHECKLIST OF WHAT TO DO

Are you fully prepared...have you.... 

...Determined that your prodcut actually is a medical device.........?

... correctly CLASSIFIED all your Products and Accessories ?

...chosen the most appropriate CONFORMANCE ROUTE ?

... performed DESIGN VERIFICATION, even for Class I devices ?

... compiled a TECHNICAL FILE for each Product Group ?

...conducted RISK ANALYSIS as part of RISK MANAGEMENT ?

…compiled the relevent CLINICAL EVALUATION DATA ?

... full confidence that all your DOCUMENTATION complies ?

... full confidence in your QUALITY MANAGEMENT SYSTEM ?

... chosen the right NOTIFIED BODY with the appropriate Scope!

... effectively addressed the THREE POST SALES ISSUES ?

... correctly made the DECLARATION of CONFORMITY ?

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