DNV GL Danmark

ISO 13485:2016

ISO_13485

The training is held online in February 2021. In March 2016 the new edition of ISO 13485 was published. Industry is now implementing this Quality Management System due to the expectations from worldwide authorities. There is a handbook, a guidance document, replacing the TR 14969. The handbook will be covered as well. We will also discuss the benefits with ISO 13485 versus the MDSAP. Interface standards will be discussed.

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. Anette is also a member of the new task force for Annex L (high level structure).

Language:

Course material is in English.

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

Program:

Two days course including a written examination (multiple choice questions)

Day 1:

Background and introduction to ISO 13485

The chapters 4 – 7.2 with exercises and workshops within policy, objectives and competence profiles. Examples to illustrate industry practice. Practical guide information throughout and reference to other guidance documents.

Day 2:

Continue chapter 7 and 8 with workshops within the CAPA process. Examples to illustrate industry practice. Practical guide information throughout and reference to other guidance documents.

Examination.

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Hvornår:

Add to calendar 2021/02/02 09:00 2021/02/03 18:00 ISO 13485:2016 The training is held online in February 2021. In March 2016 the new edition of ISO 13485 was published. Industry is now implementing this Quality Management System due to the expectations from worldwide authorities. There is a handbook, a guidance document, replacing the TR 14969. The handbook will be covered as well. We will also discuss the benefits with ISO 13485 versus the MDSAP. Interface standards will be discussed.
https://www.dnvgl.dk/training/iso-13485-2016-156033
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Varighed:

The training is held ONLINE in February 2021 and onsite as classroom in September 2021. 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. Anette is also a member of the new task force for Annex L (high level structure).

Language:

Course material is in English.

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

Program:

Two days course including a written examination (multiple choice questions)

Day 1:

Background and introduction to ISO 13485

The chapters 4 – 7.2 with exercises and workshops within policy, objectives and competence profiles. Examples to illustrate industry practice. Practical guide information throughout and reference to other guidance documents.

Day 2:

Continue chapter 7 and 8 with workshops within the CAPA process. Examples to illustrate industry practice. Practical guide information throughout and reference to other guidance documents.

Examination.

Interne kurser for din virksomhed

Kontakt os