Courses

 

MEDICAL DEVICE COURSES – FEBRUARY 2018

Clinical investigations with medical devices – gathering data for a CE-mark
Clinical data demonstrating safety and performance according to essential requirements is pivotal to CE marking a medical device. Based on the latest legislation and guidelines the course will focus on designing, preparation, execution and reporting of clinical investigations of medical devices. The course will amongst other things cover: 

  • Statistical considerations when designing clinical investigations such as analysis population, method of analysis, sample size calculation, how to handle missing data  
  • Designing clinical investigations to minimize bias 
  • Conducting clinical investigations in compliance with ISO14155 – Clinical investigation of medical devices for human subjects – Good clinical practice  & European Medical Device Regulation
  • Safety reporting requirements when conducting clinical investigations 

 The two day course has been established for professionals who are involved in designing, conducting and reporting clinical investigations of medical devices. This course will cover the full range of activities related to the collection of clinical evidence for pre and post market studies. It will provide participants with information on the European regulations and guidelines for gathering clinical evidence and conducting medical device clinical investigations in order to be compliant
Date: 26-27 February 2018
Location: Tuborg Parkvej 8, 2900 Hellerup (Copenhagen, DK)
Course instructor: Camilla Felsvang Vibjerg, Charlotte Hindsberger and Henrik Tønsberg
Price: DKK 11,995

Clinical evaluation of medical devices – a practical approach
Clinical evaluation of clinical date which demonstrate safety and performance according to essential requirements is essential to CE marking a medical device. The one day course has been established specifically for professionals who are involved in clinical evaluation of medical devices and in-vitro diagnostic products
Based on a number of practical examples and cases this course will cover the full range of activities related to the clinical evaluation and clinical evaluation report. It will provide participants with information on the European regulations for clinical evaluations in order to be compliant
Date: 28 February 2018
Location: Tuborg Parkvej 8, 2900 Hellerup (Copenhagen, DK)
Course instructor: Camilla Felsvang Vibjerg, Charlotte Hindsberger and Henrik Tønsberg
Price: DKK 6,495

Clinical investigations with medical devices + Clinical evaluation of medical devices
Date: 26-28 February 2018
Location: Tuborg Parkvej 8, 2900 Hellerup (Copenhagen, DK)
Course instructor: Camilla Felsvang Vibjerg, Charlotte Hindsberger and Henrik Tønsberg
Price: DKK 14,995

 

MEDICAL DEVICE COURSES – SPRING 2018

Medical Device Regulation (MDR)
A two-day course on the forthcoming Medical Device Regulation, which will eventually replace the Medical Device Directive.
Date: 4-5 April 2018
Location: Tuborg Parkvej 8, 2900 Hellerup (Copenhagen, DK)
Course instructor: Anette Sjögren
Price: DKK 11,995

ISO 13485:2016
A complete review of the standard, including an exam.
Date: 18-19 April 2018
Location: Tuborg Parkvej 8, 2900 Hellerup (Copenhagen, DK)
Course instructor: Anette Sjögren
Price: DKK 11,995

 
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: 24 April 2018
Location: Tuborg Parkvej 8, 2900 Hellerup (Copenhagen, DK)
Course instructor: Anette Sjögren
Price: DKK 6,495

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: 8 Mai 2018
Location: Tuborg Parkvej 8, 2900 Hellerup (Copenhagen, DK)
Course instructor: Anette Sjögren
Price: DKK 6,495

 

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: 9 Mai 2018
Location: Tuborg Parkvej 8, 2900 Hellerup (Copenhagen, DK)
Course instructor: Anette Sjögren
Price: DKK 3,500

 
Clinical Evaluation Report - ½ day course
Date
: 9 Mai 2018
Location: Tuborg Parkvej 8, 2900 Hellerup (Copenhagen, DK)
Course instructor: Anette Sjögren
Price: DKK 3,500

 

We offer a discount of 10% if you sign up more than 2 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 Nemko 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