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Medical Device Regulatory Project Management

Utilise project management techniques to navigate key regulatory challenges

25 - 26 February 2019

Radisson Blu Edwardian Grafton, London

How can regulatory affairs professionals benefit from project management in the medical devices industry?

2020 marks an important date for the Medical Devices industry, as the European Union's Medical Device Regulation (MDR) will take effect. Two years after, the In Vitro Diagnostic Medical Devices (IVDD) will follow. These regulations are set to constitute major changes for the industry, and these changes bring a high degree of uncertainty with them. Recognized as a key principle for success, effective project management could be applied to regulatory challenges for medical devices and help navigate through this trying time.

Over two days, delegates will gain a solid understanding of the core ingredients needed for a successful project management, with insight into future challenges and how to tackle them. Delegates will be able to cement this knowledge through case studies and practical exercises.

  • Introduction to Project Management
  • Applying Regulatory Requirements to Project Management
  • Managing Regulatory Changes and Communicating with Authorities
  • A Closer Look at Clinical Evaluation in a Project
  • Applying Risk Management in a Project
  • Managing Project Cycles
  • Cement this knowledge through practical group exercises and case studies


Heikki Pitakänen
Heikki is the CEO /founder of his own consultancy company Lean Entries Ltd, advising on medical device regulatory compliance for both start-up and experienced teams across the globe by utilising both traditional and lean digital methods. Heikki previously worked as a team leader at SGS, providing medical device manufacturers with NB, CBTL and training services, among others, for worldwide market access. He is a member of the CEN-CENELEC Advisory Board for Healthcare Standards.


This course is ideal for professionals with a minimum of 3 - 5 years' experience, or those who are mid to senior level regulatory affairs professionals in the medical devices industry. 
Additionally, both experienced project managers and project managers looking to apply their knowledge in the medical device industry would benefit, as this course focuses on managerial and leadership development - alongside new Medical Device Regulation (MDR).

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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