If you are working in the medical device industry or planning to break into it, you already know how critical...

International standards and global regulations define medical device supplier management as a systematic, risk-based oversight process of external parties that provide materials,...

One of the core QMS principle enumerated in the ISO13485 is the Plan-Do-Check-Act (PDCA) cycle. The cycle requires that you...

ISO 13485 and FDA’s QMSR are now functionally very close: ISO 13485:2016 is the core of the new 21 CFR...

The ISO13485 in its clauses 4.2.4 and 4.2.5 lists the requirements for document retention. The retention is at 2 levels:...

Three years into my regulatory consulting career, I walked into a mid-sized medical device company for a pre-audit assessment. Their...