Tips for Updating Clinical Evaluation Reports (CER) and MEDDEV 2.7/1 rev 4

As many veteran QA/RA professionals are painfully aware, the days of a 10-page Clinical Evaluation Report (CER) are a blissful memory of a bygone era. Today’s medical device CERs are now substantial in content, dynamic through the entire life cycle of a product, and essential for maintaining certification in the EU and other markets. The CER is intertwined with the larger assortment of technical documentation that includes your risk management file and postmarket surveillance data. Countries such as China and […]

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The MDSAP Audit Model: What to Expect and How to Prepare

Unless you’ve spent several years adrift on a raft in the South Pacific, you’ve probably heard about the Medical Device Single Audit Program, known as MDSAP. At Oriel STAT A MATRIX, many of our medical device clients ask us about the program, how to prepare for it, and how an MDSAP audit differs from a typical ISO audit or FDA inspection. Before we get into that, let’s take a step back. What is MDSAP? The Medical Device Single Audit Program […]

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Medical Device Quality Management System (QMS): What It Is, Where It’s Required, and Key Regulations to Know

This is blog post 1 of 3 in our series on Medical Device Quality Management Systems. If you already know the basics, skip to our second post on key components of a QMS. We’ve combined all three posts into one easy-to-read white paper, plus added some extras. Download it here. If you’re new to the medical device industry or simply need to brush up on quality system compliance, you probably have many questions that begin with what, where, why, and […]

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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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