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Dates TBC

LIVE Online Course

Learn how to apply project management skills to implement medical device regulatory changes and maintain compliance

Course Overview

How can regulatory affairs professionals add value and efficiency into regulatory compliance practices in medical device development projects? Join us this February to find out.

With the extension of the EU MDR, 2021 marks an important date for the Medical Devices industry as the new Date of Application is May 2021. Just one year later, the In-Vitro Diagnostic Medical Devices Regulation (IVDR) will follow. These regulations are set to constitute major changes for the industry with more requirements, oversight and stakeholders there will have a dramatic effect on how medical device projects are run in future. Regulatory changes plus the trend towards more high tech solutions, the strategies behind a business become more crucial and the role of a project manager more vital.

This essential course will provide you with an effective and informative outlook on the regulatory essentials and project management methodologies used in regulatory affairs for medical devices. During the course, delegates will gain a solid understanding of the core ingredients needed for successful projects, and learn how to coordinate key regulatory requirements for medical devices throughout project management. In addition, this course provides an insight into the future challenges for medical devices and offers solutions to tackle them.

Attendees will be able to cement this knowledge through case studies and practical exercises.

Live Online Academies

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.

Over 2 days students will learn through:

  • Live interactive sessions
  • Direct interaction with the trainer during live sessions
  • Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
  • Revisiting recorded sessions with unlimited access for 30 days
  • Interaction with peers during live sessions and through the online forum

Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact

What will you learn?

Project Management Insights
Project Management Insights
  • Planning and Initiating the project
  • Assigning role and responsibilities in house and across boundaries
Applying Regulatory Requirements to projects
Applying Regulatory Requirements to projects
  • Role of global regulations and standards in medical device management
  • Affect of quality manager system requirements (ISO13485)
  • The impact of the move from MDD to MDR
Communicate with Regulatory Authorities
Communicate with Regulatory Authorities
  • Techniques for Audits and Technical File reviews

Clinical Evaluation in a Project
Clinical Evaluation in a Project
  • Transition to the new requirements under MDR
Risk Management Skills
Risk Management Skills
  • Apply Risk management to projects
  • Benefit-Risk Analysis
Project Cycles
Project Cycles
  • Handling change and reviews
  • Product life cycle thinking

Who is this course for?

This course is ideal for professionals with a minimum of 3 - 5 years' experience but also suitable for those who are junior to mid-level regulatory affairs professionals in the medical devices industry. It’s a great way for experienced project managers to learn the new requirements and sharpen their skills while junior project managers will get the foundations they need for project management in the new regulatory world for Medical Devices.

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.

Delegates of our live online academies said...

would attend another live online academy
found the course beneficial to their day to day role
would recommend the course to others

25% discount on Routledge books

As a student on the course, you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge website

Examples of books and eBooks within medical devices include:

  • Medical Device Quality Assurance and Regulatory Compliance
  • Medical Instruments and Devices: Principles and Practices
  • Medical Device Packaging Handbook, Third Edition
  • Medical Device Regulatory Practices: An International Perspective
  • And more