DNV GL Danmark

ISO 13485:2016

ISO_13485

During the last five years work has been ongoing with the revision of the ISO 13485:2003. In March 2016 the new edition was published. The industry must now prepare for the new edition and find out what GAPs there are towards current quality management system. There is ongoing work with a handbook, a guidance document, replacing the TR 14969. The handbook will be covered as well.

About ISO 13485:2016

Goal:

To give an understanding of the full standard. You should be qualified as internal auditor in ISO 13485 after the course.

Who benefits:

Management, design and development engineers, QA/RA specialists, risk managers, customer support/service, clinical support, marketing, contract manufacturer and component manufacturer as applicable.

Course Leader:

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.

Language:

Course material is in English.

Presentation in English or Swedish (depending on the participants).

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Register for the training class here

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When:

1. oktober - 2. oktober 2019

Add to calendar 2019/10/01 09:00 2019/10/02 18:00 ISO 13485:2016 During the last five years work has been ongoing with the revision of the ISO 13485:2003. In March 2016 the new edition was published. The industry must now prepare for the new edition and find out what GAPs there are towards current quality management system. There is ongoing work with a handbook, a guidance document, replacing the TR 14969. The handbook will be covered as well.
https://www.dnvgl.dk/training/iso-13485-2016-156033
This only adds the event to your calendar, please remember to register for this event.
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Varighed:

Duration: 2 days

Pris:

Course fee: DKK 12.500,- (ex. VAT). Course material and certificate of participation is included in the price.

Yderligere information:

You can find our cancellation policy, terms & conditions and practical information about the course here: www.dnvgl.dk/betingelser

About ISO 13485:2016

Goal:

To give an understanding of the full standard. You should be qualified as internal auditor in ISO 13485 after the course.

Who benefits:

Management, design and development engineers, QA/RA specialists, risk managers, customer support/service, clinical support, marketing, contract manufacturer and component manufacturer as applicable.

Course Leader:

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.

Language:

Course material is in English.

Presentation in English or Swedish (depending on the participants).

Interne kurser for din virksomhed

Kontakt os