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The 2016 version of the Guide to managing risks for medical devices is now available
This bilingual guide, which was first published in 2014, and is prepared by the Technical centre for mechanical industries (Centre technique des industries mécaniques - Cetim) at the initiative of the French union for the industry of medical technologies (Syndicat national de l’industrie des technologies médicales - Snitem), is now back, with a few extra chapters including the consideration of software-related risks.
The new edition of the practical guide "Risk management for medical devices" is now available. What has been changed from the first edition, published in 2014? The guide has been updated to integrate software-related risks for the use of these products.
A key tool
This bilingual (French/English) guide prepared by Cetim, at the initiative of the Snitem, is a key tool for players in this field. In fact, any medical device placed on the European market must comply with the key safety and performance requirements of European directives, transposed in the French Public Health code. In order to obtain the right to add the CE marking to a product, the manufacturer must provide proof that the potential risks involved in using the product, throughout its life cycle, are acceptable in view of the benefits for the patient. This guide aims to assist with this process by providing a reference tool for their risk assessments and the application of their risk management policy, based on ISO standards 14971 and NF EN 62304 (for software-related risks).
One method and a few examples
This guide particularly aims to establish good, recognised, risk management practices, shared by all in the profession, and which can be used when analysing the data collected by the manufacturer, with consideration of the benefits provided to the patient. The guide includes a lexicon, a description of the general risk management policy, recommendations on how to implement the applicable process based on six key phases, tools and examples on how to apply them, and, clearly, an entire chapter on incorporating standard EN 62304 in the risk management process of ISO 14971, which also contains hands-on examples.
Publication 6D54: Risk management for medical devices" - Edition 2016 is available (access for members only) from our website, under the "Media library".
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