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Failure to establish and document finished device acceptance procedures and to adequately calibrate equipment were among the quality deviations that the FDA observed during a Sept. 15-21, 2020 inspection of Kenlor Industries’ Santa Ana, California facility. Read More
The European Commission’s Medical Device Coordination Group (MDCG) released guidance that clarifies expectations for notified bodies conducting remote audits during the COVID-19 pandemic. Read More
The UK and the European Union wrapped up a landmark trade deal on Dec. 24 — just days before the UK completed its transition out of the EU. Although not specifically targeted at medical devices, the pact acknowledges existing arrangements for devices. Read More
The commission is delaying the implementation of the EU’s landmark Medical Device Regulation until May 26, 2021, and said regulators may use their discretion in allowing some certificates to temporarily lapse during this time. Read More
The reported failures included ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the catheter’s distal-tip region. Read More