Courses


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MEDICAL DEVICE COURSES – AUTUMN 2018

Medical Device Regulation (MDR)
A two-day course on the forthcoming Medical Device Regulation, which will eventually replace the Medical Device Directive.
Date: 26-27 September 2018
Location: Strandvejen 203, 2900 Hellerup (Copenhagen, DK)
Course instructor: Anette Sjögren
Price: DKK 11,995
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ISO 13485:2016
A complete review of the standard, including an exam.
Date: 09-10 October 2018
Location: Tuborg Parkvej 8, 2900 Hellerup (Copenhagen, DK)
Course instructor: Anette Sjögren
Price: DKK 11,995
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Risk Management ISO 14971:2012
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: 23 October 2018
Location: Tuborg Parkvej 8, 2900 Hellerup (Copenhagen, DK)
Course instructor: Anette Sjögren
Price: DKK 6,495
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Usability EN IEC 62366-1:2015
An introduction to the usability engineering process and its interfaces to risk management,
design & development and post market surveillance.
Date: 24 October 2018
Location: Tuborg Parkvej 8, 2900 Hellerup (Copenhagen, DK)
Course instructor: Anette Sjögren
Price: DKK 6,495
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Clinical Evaluation Report - ½ day course
Date
: 25 October 2018
Location: Tuborg Parkvej 8, 2900 Hellerup (Copenhagen, DK)
Course instructor: Anette Sjögren
Price: DKK 3,500
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Post market Surveillance - ½ day course
An introduction to the PMS process from a regulatory perspective as well as an overview of the process and interfaces.
Date: 25 October 2018
Location: Tuborg Parkvej 8, 2900 Hellerup (Copenhagen, DK)
Course instructor: Anette Sjögren
Price: DKK 3,500
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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