Courses


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MEDICAL DEVICE COURSES – AUTUMN 2019

Medical device Regulation (MDR)
A two-day course on the forthcoming Medical Device Regulation, which will replace the Medical Device Directive.
Date: 10-11 September 2019
Location: TBD
Course instructor: Anette Sjögren
Price: DKK 12,500
More information will follow

 

ISO 13485:2016
A complete review of the standard, including an exam.
Date: 24-25 September 2019
Location: TBD
Course instructor: Anette Sjögren
Price: DKK 12,500
More information will follow

 

Risk Management ISO 14971:2012
Incl. updates on the FDIS 14971:2019 and 24971:2019
Basic introduction to the requirements on the Risk Management according to 14971:2012. The course will also give tools and practical examples (workshop) on how to comply with the requirements.
Date: 1 October 2019
Location: TBD
Course instructor: Anette Sjögren
Price: DKK 6,800
More information will follow

 

Clinical Evaluation Report (CER)
This half day course will focus on the regulation of the MDD and the associated MEDDEV guidance- Including how to make a literature search,  plan for clinical evaluation, make the report and information on requirements for the feedback system.
Date: 2 October 2019 (1/2 day)
Location: TBD
Course instructor: Anette Sjögren
Price: DKK 3,675
More information will follow

 

Post Market Surveillance (PMS)
An introduction to the PMS process from a regulatory perspective as well as an overview of the process and interfaces.
Date: 2 October 2019 (1/2 day)
Location: TBD
Course instructor: Anette Sjögren
Price: DKK 3,675
More information will follow

 

We offer a discount of 10% if you sign up 2 or more participants for the same course.
All prices are per person and excluding VAT. 

If you require further information about a specific course please contact 
Zeshaan Sayd, zeshaan.sayd@presafe.com
 

All our courses can be tailored specifically to your company and carried out in-house or at another preferred venue. Please contact Presafe Denmark A/S for further information about company tailored courses on presafedk@presafe.com  

Presafe Denmark A/S and DNV∙GL Presafe AS also provides tailored training programs based on the major international and local standards in your field of business, helping your business to be better equipped to implement and certify your products or management system Contact us today to discuss your plans and how we can help! 

Presafe Denmark A/S cannot be held liable if the course instructor becomes ill, unable to hold the course or similar, which leads to cancellation of the course(s).
If you're unable to participate in an already registered course, our cancellation policy is as follows:
 

  • Cancellation 30 days prior to course start date will be free of charge. 
  • Cancellation up to 15 days prior to course start date will be invoiced at 50% of the course fee 
  • Cancellation 14 days or less prior to course start date will be invoiced at 100% of the course fee 
  • Course registration can freely be transferred to e.g. a colleague  

Clinical Evaluation Report (CER)
In-depth and hands on experience on how to prepare a Clinical Evaluation Report by working on the different aspects.
Date: 8 May 2019 (1/2 day)
Location: Tuborg Parkvej 8, 2900 Hellerup (Copenhagen, DK) Course instructor: Anette Sjögren
Price: DKK 3,675