Medical devices. Quality management systems. Requirements for regulatory purposes British Standard / European Standard / International Organization for Standardization / 31-Mar-2012 / 86 pages ISBN: 9780580778605
In 2011 the European Commission raised a concern around the legal text supporting presumption of conformity to the Medical Device Directives (Annexes ZA, ZB, ZC) in EN ISO 13485:2003. The outcome was that CEN decided to publish a new edition of the standard (EN ISO 13485:2012). This standard has a revised Foreword and Annexes ZA, ZB and ZC, but the core text remains unchanged.
Replaces BS EN ISO 13485:2003 which remains current
All current amendments available at time of purchase are included with the purchase of this document.
Keywords: Medical equipment; Medical instruments; Medical technology; Quality management; Quality assurance systems; Acceptance (approval); Management
Product Code(s): 30258513,30258513
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