Expert Quality Assurance consulting and auditing services for GMP, GCP, GLP, and PV quality systems.
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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
In January of 2016, FDA released new guidelines for postmarket cybersecurity measures in medical devices. These offer a number of best practices designed to assess and...Continue Reading