Medical Devices CE Marking Training Course

You could save time getting your products to market by taking our three day Medical Devices CE Marking training course. Our qualified tutors have trained over 70% of the world's top 100 medical device companies and are experts in their field. They will help you to understand the entire CE Marking process in line with the European Medical Devices Directive (MDD).

Become an expert in the regulatory requirements and you could speed up the time it takes to get your products to market.

Medical devices training expertUnsure if this course is for you? Watch our free taster webinar with Suzanne Halliday, our Head of Medical Devices training. Suzanne has developed and delivered numerous presentations at international conferences on compliance to the MDD.

Who should attend?

  • Regulatory, quality, design, development, manufacturing, marketing managers
  • Organizations preparing "own branding" or "private labelling" of devices
  • Potential internal auditors and others who need an in-depth knowledge of the requirements of the medical devices directives
  • All personnel who need to understand the medical device regulation requirements
“The course content interspersed with plenty of practical group work was very well constructed.” -Steve Russell, FFEI Ltd.

What will I learn?

On completion of this training, participants will be able to:

  • Explain the European CE Marking approach and its legal and operational basis
  • Explain the structure and purpose of the medical devices directive
  • Implement the EU risk classification criteria for medical devices
  • Identify the conformity assessment routes and quality assurance requirements for the various risk classes
  • Describe the role of the essential requirements as the basis for CE Marking, including the use of standards
  • Explain the importance and role of clinical data
  • List labelling requirements
  • Identify the regulatory significance of risk management and process validation
  • Identify the necessary steps required for post market surveillance for different risk classes
  • Interpret the criteria for reporting adverse incidents under the vigilance system
  • Define the manufacturer's regulatory responsibilities, including reporting of changes to products and QMS system to the Notified Body
  • Identify technical documentation requirements
  • Identify the relevance of recent changes to the medical device directives
  • Conduct internal and external audits for compliance with the directives

How will I benefit?

  • Benefit from CE Marking expertise within your organisation
  • Work without uncertainty when placing products on the EU market 
  • Gain recognition as a producer of products with CE Marking
  • Improve the quality and safety of your medical devices
  • Increase EU market access and boost customer confidence

What's included?

  • Training course notes
  • Lunch and refreshments
  • Certificate
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  • Suitable for small groups
  • Suitable for single person
  • Learn from other organizations


  • Suitable for large groups
  • Flexible & convenient
  • Tailored for your needs

Mode of Payment

You can make payment through Cheque, NEFT transfer, e-payment or UPI payment.

Below are the details 

BSI Group India Private Limited 
Current Account No.: 166045294001
HSBC Bank, 25, Barakhamba Road, New Delhi-110 001
IFSC/RTGS Code: HSBC0110002
Swift Code: HSBCINBB
UPI Code: bsiindia@hsbc

Please note: Service tax will be charged extra as per prevailing Government rates.

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