Most people skim past ISO 13485 §7.1 and §7.2 to get to design controls. That’s a mistake — those two clauses introduced requirements the old QSR didn’t really have, and an FDA inspector auditing to ISO 13485 will know exactly where to look.
ISO 13485 Clause 6 turns training into competence, widens infrastructure to include the server closet, and makes contamination control a written procedure. Here’s what the resource clause actually requires — and where the old QSR wasn’t paying close enough attention.
ISO 13485 Clause 5 is more directive than the old §820.20 — measurable objectives, specified management review inputs and outputs, and a management representative with real authority. And with §820.180(c) gone, those records are now FDA-readable.
ISO 13485 Clause 4.2 restructures the way medical device manufacturers think about documentation — collapsing the DMR, DHR, and DHF into the Medical Device File, and eliminating the old QSR exemption that kept your audit reports out of FDA’s hands. Here’s what that means in practice.
Your contract manufacturer has ISO 13485 certification and a solid QMS. That’s great — and it still doesn’t satisfy your oversight obligations as the legal manufacturer. Here’s what QMSR and ISO 13485 actually require of each party when manufacturing is outsourced.
Section 820.45 is one of only two places in the entire QMSR where FDA stepped in and said ISO 13485 wasn’t sufficient. That’s worth paying attention to — especially if device labeling errors have ever appeared on your watch.
Section 820.35 is where the QMSR gets specific about records — particularly complaint files and servicing records. It’s not dramatically different from what you were doing under the old QSR, but there are real changes worth knowing, and one of them involves UDI.
We pulled three of our resident experts into one (virtual) room to tackle the five AI questions medical device manufacturers are wrestling with right now. There was banter. There were citations. Norma kept her composure.
Section 820.7 is three short paragraphs, and most people skim right past it. Don’t. It’s the provision that turns ISO 13485:2016 from a helpful standard into a legal requirement — and it fundamentally changes how you read the entire QMSR.
Section 820.10 is where the QMSR stops asking whether you have a quality system and starts asking whether it actually works. Clara explains what ‘demonstrate’ really means to FDA, what changed from the old QSR, and how to make sure your QMS can stand up to scrutiny.