Updated Medical Device Guidance Jan 2021
Zener Engineering Services Ltd • 31 March 2021
MD Management for Healthcare Providers
The purpose of this MHRA document is to outline a systematic approach to the acquisition, deployment, maintenance (preventive maintenance and performance assurance), repair and disposal of medical devices and medical device training.
It is intended primarily for people in hospital-and community-based organisations that are responsible for the management of reusable medical devices, to help them set up and develop systems that promote the use of the medical devices for safe and effective health care. This document replaces the following:
- DB 2006(05) Managing Medical Devices. Guidance for healthcare and social services organisations, November 2006
- DB 2005(03) Guidance on the safe and effective use of batteries and chargers for medical devices, October 2005.
The latest version includes:
- Regulatory updates
- Minor text changes
- Update of references
- Minor text changes to all sections
- Regulatory updates
- Remove tables and text boxes
Also updated are:
- Management of In Vitro Diagnostic Medical Devices Jan 2021
- Management and use of IVD Point-of-Care Test Devices Jan 2021
If you are an NHS trust with an underperforming EBME department,
ZES can help you save money and improve the service significantly.
See our dedicated EBME page
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"I am writing to provide an excellent professional reference for Zener Engineering Services, who were brought in to review the EBME department and make suggestions for improvement, with regards to ways of working, quality systems, personnel structure, staff bandings and management issues.
Due to the excellent quality of the audit report submitted ............ the documented improvements were sufficiently valued to warrant implementation.
Band 8B Head of Clinical Engineering
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