Spiral Medical Development

The FDA QMSR aligns US rules with ISO 13485:2016, but gaps remain. Understand the key differences and plan a smooth transition with expert ISO 13485 consulting.

The FDA’s Quality Management System Regulation (QMSR) has officially harmonized 21 CFR Part 820 with the international ISO 13485:2016 standard (and Clause 3 of ISO 9000:2015). While this regulatory alignment promises a more streamlined path to global market access, treating the transition as a simple “copy-paste” exercise presents significant compliance risks. Although the FDA incorporates ISO 13485:2016 by reference as the baseline, the agency has not abandoned its unique st

The specialist CER partner medical device manufacturers trust to get it right — first time. Getting a Clinical Evaluation Report (CER) wrong is potentially a costly mistake for commercial timelines. Since it has become the law of the land (specifically in the EU), Notified Bodies review CER submissions fairly strictly under EU MDR 2017/745 — and the consequences of non-compliance extend far beyond a simple request for additional information. Delayed CE marking, stalled produc

Navigating the transition from MDD to EU MDR 2017/745 has turned Clinical Evaluation Reports (CERs) into perhaps the single most important gateway to CE certification in the EU. A CER is no longer a simple summary that gets stuck in a drawer after writing; it is a rigorous, evidence-based demonstration of safety and performance that must withstand the scrutiny of Notified Bodies. Spiral Medical Development (SMD) specializes in clearing these regulatory hurdles. We provide en

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