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ISO 13485
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
An audit always finds areas for improvement.
In 2016, the latest edition of ISO 13485 standard for the Medical Device Industry was published by ISO. The new 13485:2016 has some significant changes and any organization with a certification needs to understand the impact.Intended Audience:This course is intended for one Internal Auditor to:
- management and active teams
- internal auditors and
- persons of interests in ISO 13485
| Duration: | 365 days |
| Price: | $895.00 |
In 2016, the latest edition of ISO 13485 standard for the Medical Device Industry was published by ISO. The new 13485:2016 has some significant changes and any organization with a certification needs to understand the impact for an easy transition.This course covers the changes on a clause-by-clause basis.
Because it covers Objective Evidence - it is a very useful course for ISO 13485 Internal Auditors.
| Duration: | 12 months |
| Price: | $1,295.00 |