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ISO 13485 - Wikipedia

ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard ...

ISO 13485:2003 - Medical devices -- Quality management ...

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related ...

ISO 13485:2016 - Medical devices -- Quality management ...

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related ...

ISO 13485 2016 Medical Device Quality ... - praxiom.com

Use ISO 13485 2016 to show that your organization is consistently capable of providing medical device products that meet customer expectations and comply with ...

ISO 13485 Consulting and Certification - Emergo

We specialize in helping medical device and IVD companies achieve ISO 13485 certification. Let us help you implement ISO or modify your existing QMS.

ISO Medical Device Standards - MasterControl Inc

Learn more about ISO Medical Device Standards and how MasterControl Audit software can streamline the audit process.

Quality Management System (QMS) ISO 13485 Certification ...

ISO 13485:2016 is here. The world’s most popular standard for medical devices quality management has been revised for the first time since 2003.

Medical devices — Quality management systems ...

ISO (the International ... Medical devices — Quality management systems — Requirements for regulatory purposes 1 Scope 1.1 General ... medical device(s) ...

Understanding ISO 13485 - Quality Magazine | Quality ...

ISO 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 ...

Regulatory Training | Medical Devices | BSI America

BSI Medical Device Training: Helping to make regulatory compliance excellent with online, public and inhouse training courses from BSI.