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.
This essential course will provide you with an effective and informative outlook on how a project management methodology can be used in regulatory affairs for medical devices. Over two days, delegates will gain a solid understanding of the core ingredients needed for successful project management, and learn how to coordinate key regulatory requirements for medical devices through effective project management techniques. 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 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).