Speciality Designed Maintenance Management Required Medical Device

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Maintenance and repair of medical devices - ScienceDirect

https://www.sciencedirect.com/science/article/pii/B9780128134672000353

The maintenance requirements associated with healthcare technology have to align with the manufacturer specifications, the organization’s medical equipment management plan, and regulatory bodies. The manufacture specifications and …

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

Medical Device Listing - 21CFR Part 807 Manufacturers must list their devices with the FDA. Establishments required to list their devices include: …

Medical equipment maintenance | HFM | Health Facilities Management

https://www.hfmmagazine.com/articles/1493-medical-equipment-maintenance

Medical Device Safety | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/medical-device-safety

Medical Device Safety | FDA Medical Device Safety The FDA monitors reports …

A Modern Approach for Maintenance …

https://www.intechopen.com/chapters/72427

Maintenance is a crucial topic in the life cycle management of medical equipment. Evidence-based …

Association for the Advancement of Medical …

https://www.aami.org/docs/default-source/uploadedfiles/filedownloads/whitepaper/qs-white-paper-21cfr820-13485.pdf

Association for the Advancement of Medical Instrumentation

USER GUIDE: WHO technical specification for …

https://cdn.who.int/media/docs/default-source/medical-devices/technical-specifications/user-guide.pdf?sfvrsn=2c161505_5&download=true

concerning procurement, maintenance, safe-use, waste management, and other technical issues. ... The need to have a set of TS for specific medical devices required for priority …

Equipment Maintenance: ISO 13485 Requirements

https://www.qualitymeddev.com/2021/09/06/equipment-maintenance-13485/

This is a key requirement for an efficient equipment maintenance according to ISO 13485. It is the responsibilities of the organization to determine what are the …

Managing The Device Master Record …

https://www.arenasolutions.com/resources/articles/device-master-record/

The Device Master Record (DMR) is an all-encompassing collection of documents and records (including device specifications, process specifications, quality assurance …

DESIGN : Requirements Management in Medical Device …

https://www.mddionline.com/news/design-requirements-management-medical-device-development

Requirements management is defined as a systematic approach to eliciting, organizing, documenting, and managing both the initial and the changing requirements of a system. …

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