MDTI is part of the Knowledge & Networking Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa

Medical Device Regulatory Project Management

Utilise project management techniques to navigate key regulatory challenges

8 - 9 July 2019

Radisson Blu Edwardian Kenilworth, London

How can regulatory affairs professionals add value and efficiency into regulatory compliance practices in medical device development projects?

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. Among these changes and the ever-increasing intelligence of health tech solutions, it is more important than before to adopt modern business thinking into regulatory affairs.

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. Over two days, 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.

Delegates will be able to cement this knowledge through case studies and practical exercises, with additional time on the course provided to discuss the implications of Brexit.

  • Applying Regulatory Requirements to Project Management
  • Communicating and Managing the Regulatory Requirements within a Project
  • 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 the 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 junior to mid 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 

 

 

You may also be interested in...