Yes it’s true – the US FDA is shifting toward ISO 13485.
But how much and how soon?

Earlier this month, the US FDA officially announced their intention to shift toward international harmonization of the US Quality System Regulation (QSR). The medical device industry is likely to give a collective thumbs-up to the proposal, although its impact is unlikely to be felt anytime soon. Known more formally as 21 CFR Part 820, the FDA QSR took effect in late 1978 and predates ISO 13485, which was introduced in 1996. The fact that FDA is nixing a regulation that […]

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What does “State of the Art” actually mean in the EU’s Medical Device Regulation (EU MDR)?

Interesting factoid #1: The EU MDR 2017/745 uses the term “state of the art” no fewer than 12 times. Interesting factoid #2: The EU MDR does not define the term “state of the art.” Confused? It’s understandable. Most of us think of “state of the art” as describing the latest and most sophisticated or advanced stage of a technology. For example, most people would consider a solar-powered pacemaker to be state of the art. (Don’t hold your breath for this one to […]

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Smaller medical device companies may qualify for a 35% reduction in MDSAP audit duration…if they meet these four criteria

On October 31, 2017, Health Canada announced new guidelines intended to reduce some of the burden that the new MDSAP rules placed on smaller medical device companies. At that time, they promised a 10-20% reduction in audit times for companies with fewer than 45 employees. However, it seems industry was unimpressed with those efforts, because now Health Canada is recommending even more changes to all members of the MDSAP Consortium (Australia, Brazil, Canada, Japan, US). These changes affect the duration […]

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Health Canada realizes that MDSAP is a burden for manufacturers. Here’s how they plan to help.

The Medical Device Single Audit Program (MDSAP) implementation date seemed light years away when it was first announced in late 2013. But with a January 1, 2019 deadline looming, officials at Health Canada are hearing that many manufacturers simply won’t be ready in time or, even worse, have decided that the cost and hassle of dealing with MDSAP isn’t worth the effort to sell in Canada. Cognizant of the challenges faced by industry, officials are trying to help…kind of. Health […]

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