FDA 21 CFR Part 11 Compliance for Medical Device Manufacturers: Are You Complying With These Four Critical Requirements?

The first paragraph of 21 CFR Part 11 seems disarmingly straightforward. It says: “The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.” So simple…or so it seems. But as you are discovering, the “devil is in the details.” The Top Four Part 11 Compliance Requirements for Medical Device Companies […]

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Futureproofing Your Medical Device QMS for Global UDI Expansion

The Unique Device Identification (UDI) system was conceived as a means of harmonizing identification of medical devices throughout the distribution chain and at the point of use. UDI is required on labeling for Class II and III devices sold in the US (Class I enforcement begins September 2022), and you are likely aware that it’s coming soon under the EU MDR. Less commonly known is the fact that other countries and regions around the globe are also beginning to require […]

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2019 IMDRF Guidance Changes Related to Clinical Evidence, Evaluation, and Investigations

Since the release of the European Medical Device Regulation and MEDDEV 2.7/1 Rev 4, medical device regulatory professionals are craving clarity on issues related to clinical data that supports new global submissions and ongoing regulatory compliance. Late in 2019, the International Medical Device Regulators Forum (IMDRF) issued three updated guidance documents that clear up confusion and harmonize the guidance with the EU MDR. They include: Clinical Investigation – IMDRF MDCE WG/N57FINAL:2019 (formerly GHTF/SG5/N3:2010) Clinical Evaluation – IMDRF MDCE WG/N56FINAL:2019 (formerly […]

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The FDA QSIT: Understanding What Happens During a Medical Device QMS Inspection

QSIT Audit

Unlike Regulatory Authorities in most other countries, the US Food and Drug Administration (FDA) relies on random inspections to keep medical device manufacturers honest. Random audits can occur at any time, and that means manufacturers must always remain in compliance with the FDA Quality System Regulation (QSR). There are simply too many medical device manufacturers for FDA to inspect annually, so FDA prioritizes its limited inspection staff according to the risk posed by manufacturers and their devices. Some companies get […]

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