Essentials of European Medical Device Regulatory Affairs
Essentials of European Medical Device Regulatory Affairs

Course overview 

This online course provides an opportunity to gain a basic understanding of the European medical device regulatory requirements and how to comply with them.

This is an interactive eLearning course delivered by tutors who have many years of regulatory experience and are currently working in the industry. 

 

Benefits to delegates

  • Develop a broad understanding of the regulatory affairs profession within the medical devices industry. 
  • Meet and learn from experts in the field   

CPD: This course provides 6 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

  • Medical Device Regulatory Affairs: setting the scene and scope
  • Standards, QMS and CE mark
  • The role of manufacturers
  • Registration, requirements and traceability of devices
  • The Regulatory Authorities
  • The classification of devices
  • Clinical evaluation and investigation
  • PMS Vigilance and Market Surveillance 
  • Confidentiality, data protection, funding and penalties
  • Combination products
  • General Safety requirements and Labelling
  • Technical Documentation and Conformity Assessment

Presenters

Speakers include: 

  • Janis Bayley, Eli Lilly & Company Ltd
  • Theresa Jeary, BSI Group
  • Janine Jamieson, International Pharmaceutical Quality (IPQ)
  • Anne Leijsen, Avania Clinical
  • Alwin van den Broek, Avania Clinical

Suitable for

This course is designed for those:

  • Regulatory affairs professionals who require an overview of medical devices 
  • Professionals involved in the research and development of medical devices who need to understand how their products will be regulated
  • Who work in functions allied to medical device regulatory affairs (such as marketing, medical, quality, packaging and legal)
  • From related professions (law, pharmaceutical manufacturing, marketing and sales, healthcare, administration, project management)
  • Those who work in regulatory authorities and those in the regulatory sector
  • Who are considering a career in medical device regulatory affairs

Price   

Standard

  • Member/Non-member: £300 +VAT

*VAT, if applicable, is charged at VAT of 20%

Access

Once you have made the purchase, you will receive an email from topclass@topra.org with a link to the online learning activity within 24 hours. Once received, simply click on the link in the email to access the learning activity. You will have access to the online learning activity for six months from the day of purchase. Please note, if you select the pay later option, you will not have access until payment has been cleared.

Terms and conditions

Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.
360.00