Euromcontact: Action needed

November 29, 2016 Posted by Euromcontact

Euromcontact is willing to organize a workshop/ training session on ISO 13485 – 2016 version, provided that there are enough participants to the workshop.
The workshop would be run by an independent expert, who has a concrete knowledge of the MD and ISO norm; and acts as an auditor for a notified body in the field of medical devices. The workshop would be designed to meet the concrete needs of the participants. The first session will show the differences and main changes from the 2003 version; second session will train participants on how to implement the new norm in the manufacturing site; revert with very concrete answers and actions and explain the expectations from notified body when auditing on the implementation of the norm. Participation is open to all members, national associations, companies and EFCLIN without any restriction. A registration fee of 150 € to attend the workshop will be asked– the fee will cover the costs of accommodation for the day and part of the training costs.
Days proposed for the training session are:
2nd February 2017
9th February 2017
16th March 2017.
To be most efficient, the first 2017 meeting of the Regulatory Affairs Group would be organised the day before the workshop. Find more information here

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