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Understanding the Medical Device Regulation

Understand the regulations which directly apply to your product

13 - 22 October 2020

New LIVE Online Academy

LIVE ONLINE ACADEMIES

In light of the uncertain times we’re facing at the moment, gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. 

Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-2.5 hours online.

All sessions will be recorded and uploaded to your virtual learning environment which you will get access to for a month. As part of this you will also be able to access a forum where you can communicate with your trainer and peers on the course.

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.

For more information and a comparison with other digital study modes, download the digital training guide.

In Europe, products classified as medical devices are subject to stringent regulatory requirements to ensure the product’s safety & performance. To maintain patient safety the EU introduced the Medical Device Regulation (MDR) transforming and modernising the older Directives. Whether you are new to regulatory affairs, the MDR or are branching out from other areas of the wider medical device industry, this fundamental-level course will detail the EU regulatory requirements throughout the entire product life cycle. 
 
Complemented with practical exercises and open discussions, you will gain a comprehensive overview of the essential European regulatory requirements to consider as you prepare for MDR implementation, including: the European regulatory landscape, device classification and conformity assessments, documentation and labelling requirements, post-market considerations, risk management and clinical evaluations. 

For live online academy – Richard Young

Richard Young has over 20 years’ experience in the medical device industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.

For classroom course - Anne Jury 

Anne has her own consulting company, advising on regulatory affairs and quality assurance to medical technology industries. Anne previously worked for BSI Product Certification as a medical devices notified body Certification Manager, managing BSI’s regulatory compliance for CE marking to the Active Implantable Medical Devices Directive 90/385/EEC and Medical Device Directive 93/42/ECC.  In addition, Anne worked for TUV, where she was responsible for the development of the Medical-Health-Sports (MHS) Business Unit.

  • Learn about the NEW Medical Devices Regulation and how it will impact you
  • Gain a thorough understanding of how the regulation of medical devices will change under the Medical Device Regulation for EU applications
  • Learn how to classify medical devices
  • Determine the correct information required for medical device labelling
  • Understand the role of the Notified Body and Competent Authority
  • Examine the risk management process for medical devices
  • Discuss the regulatory challenges of software and methods to tackle these problems

 

  • Regulatory Affairs professionals seeking to improve their skills in the regulatory environment
  • Those moving into Regulatory Affairs from other areas within a medical device company  (Clinical Trial Evaluations, Marketing and others)
  • Anyone wishing to update their knowledge on EU regulatory affairs

Testimonials

The course was very interactive with lots of opportunity to ask questions. It provided an excellent overview.

Clinical Trial Manager, Europe

, Moximed International GmbH

I was looking for a course which would inform and prepare me for the new MDR. The fact that we could ask questions that arose at any time was great; I enjoyed this course immensely.

Scientific Affairs European Manager, 

Moximed International GmbH

The fact that it was a small group gave us the opportunity to discuss everything with good informal contact with the trainer.

Regulatory Affairs Officer

, Barco N.V

Comprehensive course on New Regulation covering range of topics.

Consultant


Related webinars

ISO 13485:2016 – An Overview of General and Product Realisation Requirements

Led by Richard Young, trainer for MDTI's 'Managing the Transition to the new IVD Regulation' and 'Practical Guidance for Medical Device Audits and Inspections' courses, this c. 20 minute webinar covers:

- Impacts of the new revision
- New terminology
- General requirements
- Resource management
- Product realisation and design controls
- Q&A session

Medical devices software development and applications


Over c.30 minutes, this webinar explores a major area of development from the last decade. Presented by Richard Young, it covers:

- The changing regulatory environment for medical devices in Europe 
- FDA regulation 
- Key considerations in development environments 
- Key standards 

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