About ISO 13485:2016 Lead Auditor Traning for Medical Device industry
To give a basic education to gain knowledge and by that become an auditor within medical device industry focusing on ISO 13485. To give an interactive education with full involvement of participants and practical examples with exercises. Ongoing discussions to make the education beneficial to all.
Anyone who are supposed to perform audits. Usually the functions QA/RA, Supply Quality, potential internal auditors and management.
At the end of the training there will be an exam. Certificate of successful completion/Certificate of attendance will be issued after the training.
Anette Sjögren, PREVENTIA AB
Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.
Course material is in English.
Presentation in English or Swedish (depending on the participants).
The training is held in the area of Copenhagen, Denmark