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Virtual Public Workshop - Orthopedic Device Postmarket …

    https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-workshop-orthopedic-device-postmarket-review-06102021-06102021
    1. 30-day Notices, 135-Day Premarket Approval (PMA) Supplements and 7…2. Center for Devices and Radiological Health Compliance Programs(as of S…3. Design Co… See more

Medical Device Coordination Group Working Groups - Public Health

    https://health.ec.europa.eu/medical-devices-dialogue-between-interested-parties/medical-device-coordination-group-working-groups_en
    Medical Device Coordination Group Working Groups. The Medical Device Coordination Group (MDCG) deals with key issues from the medical devices sector, from Notified …

Medical Screening and Surveillance - Overview

    https://www.osha.gov/medical-surveillance
    The fundamental purpose of screening is early diagnosis and treatment of the individual and thus has a clinical focus. The fundamental purpose of surveillance is to detect and …

International Medical Device Regulators Forum (IMDRF) …

    https://www.fda.gov/medical-devices/cdrh-international-programs/international-medical-device-regulators-forum-imdrf
    The International Medical Device Regulators Forum (IMDRF) is a group of medical device regulators from around the world that have voluntarily come together to harmonize the …

Community Home - myASQ

    https://my.asq.org/communities/home/171
    Welcome to the Medical Device Division! Formerly the Biomedical Division, our website is dedicated to advancing medical device quality and compliance knowledge: addressing …

Medical Surveillance in Work-Site Safety and Health …

    https://www.aafp.org/pubs/afp/issues/2000/0501/p2785.html
    In the context of surveillance, biologic monitoring refers to the collection and analysis of blood, urine, sputum or other body fluids and tissues to look for evidence of exposure to …

Basics and Essentials of Medical Devices Safety Surveillance

    https://www.pharmatutor.org/articles/basics-and-essentials-of-medical-devices-safety-surveillance
    Medical Device Adverse Event Monitoring Centres (MDMCs) and Adverse Drug Reactions Monitoring Centres (AMCs) Healthcare facilities, including …

device group versus device category

    https://www.johner-institute.com/articles/regulatory-affairs/and-more/device-group/
    The term “medical device group” is narrower than the general device groups pursuant to MDR, because it only summarizes devices with the same intended use. ISO …

Market surveillance and vigilance - Public Health

    https://health.ec.europa.eu/medical-devices-sector/directives/market-surveillance-and-vigilance_en
    The enforcement of the harmonised legislation on medical devices is the responsibility of the authorities in EU countries. The Medical Devices Directives establish specific …

Medical Device Industry Resources

    https://www.medicaldevicesgroup.net/
    MedicalDevicesGroup.net features 1000+ archived discussions, webinars, events, resources, and premium services for the medical device industry.



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