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.
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).