Expert Quality Assurance consulting and auditing services for GMP, GCP, GLP, and PV quality systems.
We will take you all the way through to compliance following a high quality compliance audit.
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When medical devices undergo changes, it leaves sponsors asking a critical question: Does the change require a new 510(k) submission? Before trying to answer that question, it’s important to...Continue Reading
Risk management has become a central focus for regulators over the past few years, a point underscored by this year’s draft revision to ISO 13485. Despite this, many device manufacturers don’t go far...Continue Reading