We recently participated in FDA inspections using the new QMSR (Quality Management Systems Regulations). These inspections were very interesting. One was conducted at a foreign client in China the other was in the USA.

These inspections went directly to the QMSR and expected that the companies were following the new regulations.

If you are already ISO13485 certified, life will be a lot easier in dealing with these inspections. If not, be prepared to understand what the FDA’s concern are for the compliance to these new regulations. The QMSR is basically a combining the FDA’s QSR and the ISO 13485. But the FDA is leaning more to the ISO13485 terminology.

The main thing we have witnessed is the FDA concern on “risk analysis” approach to all aspects of your device design, changes, complaints, and CAPA.

The FDA is expecting a new policy manual as part of your quality system. This has been an ISO approach to the quality system. Now the one thing you will need to have in place is a RISK ANALYSIS procedure. This is a must to survive any FDA inspection.

If you are not familiar with ISO14971, Risk Analysis, you should get a copy and review and apply it to your device(s) design.

You should also be familiar with FMEA (Failure Mode Effect Analysis) which should be done as part of your design control procedures. This will help determine the risks, level of the risk and what you can do to mediate the potential risk.

Please just do the FMEA and put it away, you should be using your FMEA to determine when you learn of a problem if you had be aware of this potential risk and it had been addressed in the original FMEA. This should be used as a living document.

If you need some information on the FMEA and the risk analysis techniques, mdi can be of assistance to work with you. Just contact us at info@mdiconsultants.com and Re: FMEA/Risk Analysis.