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  Great News for manufacturers of Medical Device Accessories and products intended for general wellness!

  Overview analysis of the FDA's 2019 guidance on low-risk devices for general wellness and medical device accessories.

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  5 Similarities and Differences between Medical Device 510(k) and CE Marking Pt. 2

  Highlights of 510(k) and CE Marking similarities and differences. Explore the Quality Management System (QMS) and Documentation aspects.

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  5 Similarities and Differences between Medical Device 510(k) and CE Marking Pt. 1

  Medical Device 510(k) and CE Marking similarities and differences to help companies effectively prioritize their regulatory efforts.

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  FDA MDDS and mobile medical applications guidances

  FDA MDDS and mobile medical applications guidances; what they mean & where they apply. Article identifies common sense approach by FDA.

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  Update on IEC60601-1-2 (2014) 4th Edition

  Analysis of IEC60601-1-2 (2014) 4th Edition update. Includes examples and impact on medical device regulatory testing and commercialization.

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  Sorting Through New and Final FDA Guidance Documents

  Highlights of July and August 2014 medical device FDA guidance documents that reduce regulatory burden without compromising patient safety.

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  Increasing IVD Regulatory Success

  Tips, considerations, and techniques to increase IVD Regulatory Success that is essential for many Medical Devices.

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  Faster Market Access for Less: Medical Device Single Audit Program (MDSAP)

  MDSAP enables Medical Device companies to save in Registrar’s fees, eliminate duplication of inspections and gain faster access to markets.

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  Avoid Waste Preparing for Medical Device Regulatory Requirements

  The best way to avoid waste is to consider medical device regulatory requirements at a project outset.

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