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.
2021 marks an important date for the Medical Devices industry following the new Date of Application for the MDR in 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 are having 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.
What will you learn?
Project Management Insights
- Planning and initiating the project
- Assigning roles and responsibilities in house and across boundaries
Applying Regulatory Requirements to Projects
- Role of global regulations and standards in medical device management
- Effect of quality management system requirements (ISO 13485)
- The impact of the move from the MDD to the MDR
Communicate with Regulatory Authorities
- Techniques for audits and Technical File reviews
Clinical Evaluation in a Project
- Transition to the new requirements under the MDR
Risk Management Skills
- Apply risk management to projects
- Benefit-risk analysis
- 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.
Meet The Trainer
Heikki Pitkänen, CEO & Founder, Lean Entries Ltd
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.
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.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. MedTech Series online training courses are live courses developed by our expert faculty providing learning on a range of technical topic areas.
Students will learn through:
- Direct interaction with the trainer
- 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 email@example.com