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  2. Regulation (EU) 2017/745 - Wikipedia

    en.wikipedia.org/wiki/Regulation_(EU)_2017/745

    Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).

  3. File:The Medical Devices Regulations 2002 (UKSI 2002-618).pdf

    en.wikipedia.org/wiki/File:The_Medical_Devices...

    English: These Regulations contain the legislative measures necessary for the implementation of three European Community Directives- Council Directive 90-385-EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93-42-EEC concerning medical devices, as amended; and Directive 98-79-EC of the European Parliament ...

  4. Medical Device Regulation Act - Wikipedia

    en.wikipedia.org/wiki/Medical_Device_Regulation_Act

    Medical device cannot be classified as a class II device because insufficient information exists for the establishment of a performance standard to provide reasonable assurance of its safety and effectiveness of the device. Medical device is to be for use in supporting or sustaining human life, of substantial importance in preventing impairment ...

  5. Category:Regulation of medical devices - Wikipedia

    en.wikipedia.org/wiki/Category:Regulation_of...

    Medical Devices regulations cover all the topics related to the laws, standards or submissions process, with which compliance is required by manifold national and international bodies to commercialize a medical device

  6. Medical device regulation - Wikipedia

    en.wikipedia.org/wiki/Medical_device_regulation

    Medical device regulation may refer to: Regulation (EU) 2017/745 in the European Union; Medical Device Regulation Act of 1976 in the United States

  7. Safe Medical Device Amendments of 1990 - Wikipedia

    en.wikipedia.org/wiki/Safe_Medical_Device...

    Safe Medical Device Amendments of 1990; Long title: An Act to amend the Federal Food, Drug, and Cosmetic Act to make improvements in the regulation of medical devices, and for other purposes. Enacted by: the 101st United States Congress: Effective: November 28, 1990: Citations; Public law: 101-629: Statutes at Large: 104 Stat. 4511 ...

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  9. Title 21 of the Code of Federal Regulations - Wikipedia

    en.wikipedia.org/wiki/Title_21_of_the_Code_of...

    The 800 series are for medical devices: 803 Medical device reporting; 814 Premarket approval of medical devices [3] 820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO) [4] 860 et seq. Listing of specific approved devices and how they are classified; The 900 series covers mammography quality requirements enforced ...