QA/RA Consulting, Auditing & Training
Medical Device Cybersecurity Requirements Under the EU MDR The European Medical Device Regulation (MDR) introduced a more rigorous approach to medical device cybersecurity, making it a safety requirement for medical devices (and IVDs under the EU IVDR). With AI making its way into the healthcare space and more devices relying on connectivity to function, hackers […]
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EU MDR PMCF Requirements for Medical Devices PMS. PMSR. PMCF. PSUR. CER. If this seemingly endless list of regulatory acronyms makes you dizzy, you├óΓé¼Γäóre not alone. They all refer to different postmarket surveillance (PMS) activities or processes required to maintain compliance with the EU Medical Device Regulation (MDR 2017/745). As you probably know, the MDR […]
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How to Evaluate, Select Combination Products Suppliers Combination products are some of the most heavily scrutinized healthcare products on the market, and often involve numerous subcontractors and suppliers. For the legal manufacturers of combination products, the selection of suppliers is fraught with risk. A problem with a single component supplier can have serious implications for […]
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Understanding ALCOA Principles and FDA & EU Data Integrity Principles for Pharma RELATED TRAINING Data Integrity and Electronic Records for Pharmaceutical Companies (ALCOA+ and FDA 21 CFR Part 11) Medical Device Data Integrity and FDA 21 CFR Part 11 Compliance As regulatory and QC professionals, we all understand the important role data plays in maintaining […]
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How to Transition Your Medical Device EUA to an FDA 510(k) The COVID-19 public health emergency (PHE) declaration expired on May 11, 2023, which means termination of medical device Emergency Use Authorizations (EUAs) and pandemic-era policy enforcement is imminent. Manufacturers who previously secured an EUA need to take action now, especially if you intend to […]
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A Guide for Managers: Employee Training Requirements for Medical Device and IVD Companies Why Training Matters Countless studies have shown that successful training fosters individual and organizational effectiveness. While some companies view training as a cost to be minimized, high-performing medical device and IVD manufacturers view it as an investment that pays for itself many […]
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