DNVGL.com

Clinical Evaluation (in English)

Medical devices DNV GL

The course focus on process related to legislative requirements. Overview of clinical evaluation approach, principles and requirements related to new requirements and legislative.

Background:

The request and requirements on clinical evaluations has increased over the years and it will not become less with the coming new Medical Device Regulation. This part of course will focus on the standards and guidance given, how to make a literature search and plan for clinical evaluation, the report and the feedback system.

 

Scope:

To give an understanding of the process to run clinical evaluations and how to keep the evaluation up to date during the life cycle of a medical device.


 

Intended for:

 

Clinical affairs, QA/RA specialists, risk managers, management, design & development engineers, customer support/service and marketing.

 

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

 

Time:

2nd October 2020

Location:

DNV GL Business Assurance Czech Repulic s.r.o., Thákurová 4, 160 00 Prague 6/ HOTEL Diplomat

Price:

600,- € excluding VAT. DNV GL clients could apply 10% discount

Registration:

You can register on e-mail address: lubomira.zachova@dnvgl.com or +420 737 212 732

Note: Czech VAT will be applied for all participants.

Background:

The request and requirements on clinical evaluations has increased over the years and it will not become less with the coming new Medical Device Regulation. This part of course will focus on the standards and guidance given, how to make a literature search and plan for clinical evaluation, the report and the feedback system.

 

Scope:

To give an understanding of the process to run clinical evaluations and how to keep the evaluation up to date during the life cycle of a medical device.


 

Intended for:

 

Clinical affairs, QA/RA specialists, risk managers, management, design & development engineers, customer support/service and marketing.

 

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

 

Time:

2nd October 2020

Location:

DNV GL Business Assurance Czech Repulic s.r.o., Thákurová 4, 160 00 Prague 6/ HOTEL Diplomat

Price:

600,- € excluding VAT. DNV GL clients could apply 10% discount

Registration:

You can register on e-mail address: lubomira.zachova@dnvgl.com or +420 737 212 732

Note: Czech VAT will be applied for all participants.