Iso | Verification And Validation | Medical DeviceSeptember Medical devices - Quality management systems - Requirements for regulatory purposes Adopted ISO , third edition, February Medical devices. Quality management systems. Requirements for regulatory purposes. November Medical devices - Quality management systems - Requirements for regulatory purposes. March Medical devices - Quality management systems - Requirements for regulatory purposes. July Medical devices - Quality management systems - Requirements for regulatory purposes.
ISO 9001 documentation - Frequently Asked Questions
Quality Management System (QMS) ISO 13485 Certification
Contents 1 Scope ISO All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee.
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Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003
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The requirements and process approach are relevant to any regulated organization that designs and develops, produces, installs or services medical devices or provides related services. Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email. You may delete a document from your Alert Profile at any time. Standards Subsctiption may be the perfect solution.