Medical device

Results: 9345



#Item
81Health / Pharmaceutical industry / Business / Food and Drug Administration / Medicine / Pharmaceuticals policy / Quality management / Medical technology / Medical device / Federal Food /  Drug /  and Cosmetic Act / Risk management / Center for Devices and Radiological Health

Deciding When to Submit a 510(k) for a Software Change to an Existing Device - Draft Guidance for Industry and Food and Drug Administration Staff

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Source URL: www.fda.gov

Language: English
82Medicine / Health / Medical technology / Technology / Manufacturing / Medical equipment / Pharmaceutical industry / Food and Drug Administration / Medical device / 3D printing / Validation / Medical device manufacturing

May 17, 2016 The FDA seeks to regulate 3D-printed medical devices by Maya M. Eckstein and Paul Nyffeler Published in InsideCounsel As we previously reported, the use of 3D printing for the production of medical

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Source URL: www.hunton.com

Language: English - Date: 2016-05-18 11:22:36
83Medicine / Medical technology / European Union directives / Medical equipment / Medical device / Medical Devices Directive / ISO 14971 / Italian Device Registration

IMDRF Presentation - Jurisdictional update - EU

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Source URL: www.imdrf.org

Language: English - Date: 2015-09-07 20:17:27
84Health / Food law / Food and Drug Administration / Medicine / Pharmaceuticals policy / Healthcare quality / Drug policy of the United States / Federal Food /  Drug /  and Cosmetic Act / Medical device / United States National Marine Sanctuary / Title 21 of the Code of Federal Regulations

34268 § 71.1 Federal Register / Vol. 81, NoTuesday, May 31, Rules and Regulations [Amended]

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Source URL: cordellbank.noaa.gov

Language: English - Date: 2016-06-01 12:38:52
85

Santé Health Canada Canada LN/NH: Medical Device Licence

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Source URL: www.rapidtest.ca

Language: French - Date: 2016-04-12 15:24:33
    86Medical research / Medical ethics / Research / Applied ethics / Clinical research ethics / Clinical research / Pharmaceutical industry / Human subject research / Institutional review board / Informed consent / Clinical trial / Investigational device exemption

    Microsoft Word - SOP - Informed Consent - Types and Elements.doc

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    Source URL: research.missouri.edu

    Language: English - Date: 2015-07-01 12:44:32
    87

    Tabel van eisen verbandrichtlijnen 2010 Alle medische hulpmiddelen moeten voldoen aan de richtlijnen van de European Medical Device directiveEEC. Alle producten dienen een CE verklaring zichtbaar op de verpakking

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    Source URL: www.hetoranjekruis.nl

    Language: Dutch - Date: 2013-10-31 06:05:22
      88

      Santé Health Canada Canada LN/NH: Medical Device Licence

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      Source URL: www.rapidtest.ca

      Language: French - Date: 2016-04-12 15:24:04
        89Health / Food and Drug Administration / Pharmaceuticals policy / Food law / Personal life / Food and drink / 111th United States Congress / FDA Food Safety Modernization Act / Medical device / George P. Larrick / Criticism of the Food and Drug Administration

        U.S. Food and Drug Administration A Special Report Pathway to Global Product Safety and Quality

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        Source URL: axendia.com

        Language: English - Date: 2011-06-20 16:54:07
        90Diabetes / Blood tests / Test strip / Blood sugar / Product recall / Stericycle / Lot number / Business / Economy

        URGENT: MEDICAL DEVICE VOLUNTARY RECALL CERTAIN LOTS of TRUEread®, TRUEbalance®, TRUEtrack® and TRUEtest® BLOOD GLUCOSE TEST STRIPS June 28, 2016 Dear Valued Customer: The purpose of this letter is to inform you that

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        Source URL: www.trividiahealth.com

        Language: English - Date: 2016-06-28 15:54:08
        UPDATE