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 Australia are increasingly scrutinizing CERs and expecting them to be far more integrated into your overall regulatory processes.…

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