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2. ISO 13485 - Wikipedia

   en.wikipedia.org/wiki/ISO_13485

   ISO 13485 (1st Edition). 2000: EN ISO 13485 is published by CEN, creating a European Norm version of the international standard, and the previous European standard (EN 46001) is withdrawn. 2003: ISO 13485 (2nd Edition). 2012: EN ISO 13485 is revised so that it harmonizes with the three European directives associated with the medical sector: 93 ...

3. Device Master Record - Wikipedia

   en.wikipedia.org/wiki/Device_Master_Record

   Design History File (DHF) The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.

4. ISO 13485:2012 - Wikipedia

   en.wikipedia.org/?title=ISO_13485:2012&redirect=no

   ISO 13485:2012. Add languages. Add links ... Upload file; Special pages ... Get shortened URL; Download QR code; Print/export Download as PDF; Printable version ...

5. ISO 9000 family - Wikipedia

   en.wikipedia.org/wiki/ISO_9000_family

   ISO 13485:2016 is the medical industry's equivalent of ISO 9001. ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant to medical device manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 ...

6. images.huffingtonpost.com

   images.huffingtonpost.com/2012-08-30-3258_001.pdf

   Created Date: 8/30/2012 4:52:52 PM

7. List of ISO standards 12000–13999 - Wikipedia

   en.wikipedia.org/wiki/List_of_ISO_standards_12000...

   Download as PDF; Printable version; In other projects ... File structure; ISO/IEC 13346-5:1995 Part 5: Record structure ... ISO 13485:2016 Medical devices ...

8. Quality management system - Wikipedia

   en.wikipedia.org/wiki/Quality_management_system

   ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements.

9. College Football Playoff championship bracket: Schedule and ...

   www.aol.com/college-football-playoff...

   The new 12-team College Football Playoff is about to begin, and the journey to crown the national champion starts now.