Oriel STAT A MATRIX explains how the European Medical Device Regulation imposes new requirements on Class I device manufacturers» Read more
Industry has a tendency to adapt quickly to changing market conditions, especially when money is involved. Government, not so much. When COVID hit the US in March 2020, in-person audits came to a screeching halt. Within months, when it became clear that the pandemic wasn’t disappearing anytime soon, medical device and IVD manufacturers pivoted and within a few months were conducting remote internal audits. Still, regulators weren’t convinced about the benefits of this newfangled video technology thing. That’s finally beginning […]» Read more
Your Notified Body may ask to see your strategy for regulatory compliance during your next audit. Do you have one?
As European regulatory compliance becomes more complicated many medical device and IVD manufacturers have had their Notified Bodies ask them for a written “strategy for regulatory compliance” document. Given a choice, most regulatory professionals would prefer to not experience the same “deer in the headlights” moment these manufacturers must have had when asked for this by their auditor. The need for a regulatory strategy stems from Article 10(9a) of the EU Medical Device Regulation (MDR) or Article 10(8a) of the […]» Read more
Regulators from five countries (US, Canada, Australia, Brazil, and Japan) joined forces in 2012 with the goal of coordinating data gathering and reducing redundant audits for medical device manufacturers. The program has grown quickly. Health Canada led the way and required MDSAP certification starting in January 2019, and as of late 2019, nearly half of US manufacturers qualified for an MDSAP audit while the rest received traditional FDA inspections. At Oriel STAT A MATRIX we get many questions about MDSAP, […]» Read more