IVDR-Compliant Documentation?

Your regulatory team is über-organized and has been maintaining duplicate sets of technical documentation for your legacy devices, in compliance with the old MDD 93/42/EEC and IVDD 98/79/EC and the new MDR 2017/745 and IVDR 2017/746. You’re doing this because even though your device has a valid CE Marking certificate that expires between 2023 and 2025, the MDR and IVDR are now the law of the land and you need to manage two sets of documents to maintain compliance with […]

FDA QSR vs. QMSR: What Medical Device Manufacturers That DO NOT Have ISO 13485 Certification Need to Know

For years, US FDA has been talking about aligning the existing FDA Quality System Regulation (QSR) with ISO 13485. FDA has finally taken concrete steps to do so by issuing a draft version of the new Quality Management System Regulation (now called “QMSR”). For US companies that export and have ISO 13485 certification, the update is welcome news. For the roughly 22%* of medical device companies that sell only in the US market, the impact on their QMS will go well beyond […]

MDCG 2022-6: Making Changes to Legacy Devices Without Triggering EU IVDR Compliance

It’s no surprise that big changes are ahead for in vitro diagnostics (IVD) manufacturers selling in Europe. While many of these companies are benefitting from a delay in enforcing the full new in vitro diagnostic regulation (IVDR), about 10% of IVD manufacturers have devices in their portfolio holding valid CE Marking certificates issued under the old In Vitro Diagnostic Directive (IVDD). Those manufacturers must comply with the IVDR no later than May 26, 2025 or when their certificate expires, whichever […]

Understanding IEC/ISO 62304 and FDA Requirements for Medical Device Software Development Life Cycle (SDLC) Management

Medical device manufacturers often hit roadblocks during FDA inspections or when it comes time to submit a 510(k) application for their device. Regardless of whether your device is considered software as a medical device (standalone SaMD) or software in a medical device (SiMD), there are specific steps that must be taken regarding change and risk management from the earliest stages of development to avoid running afoul of FDA requirements with respect to medical devices’ software development life cycle (SDLC). It […]

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