Search results with tag "Of medical device"

UDI guidance: Unique Device Identification (UDI) of ...

www.imdrf.org

a. traceability of medical devices, especially for field safety corrective actions, b. adequate identification of medical devices through distribution and use, c. identification of medical devices in adverse events, d. reduction of medical errors, e. documenting and longitudinal capture of data on medical devices. 2.1 Traceability

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Managing Medical Devices - GOV.UK

assets.publishing.service.gov.uk

Managing Medical Devices January 2021 Page 7 of 46 2.4 Records Good record keeping is essential for the safe management of medical devices. All the aspects of medical device management covered within this guidance document require some degree of record keeping. The records should be maintained within one system wherever possible.

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WHO | Medical devices

www.who.int

6.3.2 Classification of medical devices 26 6.3.3 Medical device product control 27 6.3.4 Product representation control 27 6.3.5 Vendor establishment control 28 6.3.6 The control of home-use, refurbished, and donated devices 28 6.3.7 The re-use of medical devices that are labelled “for single use”29 6.3.8 Post-market surveillance 30

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Clinical Data for Medical Devices - Cromsource

www.cromsource.com

Clinical Data for Medical Devices March 2015 Page | 3 1. Regulation of medical devices in the EU: on the cusp of change To market a medical device in the EU, a manufacturer must demonstrate that the device is safe, that

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Regulatory requirements of Medical Devices in MENA …

www.dgra.de

2.2.5 Essential Principles applicable to all Medical Devices including IVD Medical Devices .13 ... Medical Devices regulation, offer a valuable contribution to ease the regulatory interconnection and intercommunication between the individual countries and the …

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MDCG 2020-10/1 - European Commission

ec.europa.eu

of medical devices under the Regulation (EU) 2017/745 May 2020 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.

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Organisations working on donations of medical equipment

www.who.int

The Bank of Medical Devices enables health stakeholders (donors) to offer medical devices and for the international aid organisations (running the projects), to obtain those that are appropriate for the needs of the healthcare facilities they support.

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Ministry of health national Policy for Management of ...

www.who.int

National Policy for Management of Medical Devices in Albania 1 Ministry of health national Policy for Management of Medical Devices in albania

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Proposed document: Software as a Medical Device …

imdrf.org

IMDRF/SaMD WG (PD1)/N23R3 3 65 Preface 66 67 The document herein was produced by the International Medical Device Regulators Forum 68 (IMDRF), a voluntary group of medical device regulators from around the world.

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Regulatory requirements of Medical Devices in MENA countries

dgra.de

I Regulatory requirements of Medical Devices in MENA countries Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels „Master of Drug Regulatory Affairs

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Classification Rules for Medical Devices - mdco.gov.hk

www.mdco.gov.hk

- 1 - 1. Introduction This document is adapted from the GHTF document GHTF/SG1N15:2006 for the principles - of medical devices classification in accordance with the requirements of the Medical …

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National Standards for the prevention and control of ...

www.hiqa.ie

Regulation — Registering and inspecting designated centres. ... infections requires a multi-targeted approach, as no single practice is responsible for reducing the risk of infection. This depends on everyone working within the service ... procurement of medical devices and equipment management of information.

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Conformity Assessment of Medical Devices Under The New …

www.mdrivdr.com

[1.] This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such

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MEDICINES CONTROL COUNCIL - mccza.com

www.mccza.com

This guideline is intended to provide recommendations to wishing to submit applications for the interested persons licensing of manufacturers, distributors and wholesalers, aregistration of medical devices and IVDs.

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MICA Freeform - Microfabrica

www.microfabrica.com

M A T E R I A L S D O S S I E R Rev.B 3 Introduction The primary standard for biological evaluation of medical devices is International Standard ISO 10993.

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Medical Devices Policy - solent.nhs.uk

www.solent.nhs.uk

1.1 This document outlines procedures and guidelines for the systematic management of medical devices and equipment throughout the whole life time cycle

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Search results with tag "Of medical device"

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