Fundamentals in Regulatory Affairs for Medtech Industry
The course will enable personnel in the medical technology industry to understand all current device and diagnostic regulations and to develop the skills necessary to address and prepare for the ever-changing global environment of regulatory affairs. Upon successful completion of the programme, participants receive 9 ECT credits of a Level 8
Member Cost: €1,950 per person
The regulatory affairs professional is critical to making safe and effective medical products available to patients worldwide. These professionals ensure compliance to international medical device regulations for safety and efficacy. Regulatory Affairs is one of the most in-demand professions in the medical device industry.
The aim of the course is to introduce participants to the Fundamentals of Regulatory Affairs, providing them with basic knowledge of the regulations as they apply to the medical technology industry. This course will cover international regulatory requirements with emphasis on the US, European Union, Japan, Australia, Canada and other global territories with market implications. Regulatory requirements for each system will be presented including classification, marketing submissions and post-approval requirements. Developing regulatory strategies for global market introduction and organising for the challenges of global regulation will be considered.
The course content will address the following themes:
1. What regulatory and certification bodies look for from Regulatory Affairs function in an organisation.
2. Similarities and differences between EU, US and Global regulatory market requirements, with special attention to the recently published MDR and IVDR texts.
3. Risk and Risk management and corresponding links to Post Market Surveillance for Regulatory Affairs.
4. Quality Management Systems and where regulations align for the Business and Regulatory function.
5. Clinical Studies and the Design Process including the various interfaces with Regulatory Affairs.
6. Significance of product labelling, associated promotional material and device changes and the watch-outs for Regulatory Affairs
Who should attend:
Entry requirement will be minimum Level 7 with two years’ experience working in a regulated environment in the life sciences sector.
Prior experiential learning will be assessed using guidelines recommended by the Academic Council of University of Limerick.
The course will be accredited by University of Limerick, with 9 credits of a level 8.
Note: Approximately 90 – 100 hours are required outside course work.
Delegate cancellation policy
Any cancellations received in writing up to two weeks prior to the event are refundable. All bookings are provisional until full payment is received.
Photography at events
There may be a photographer and videographer at the event and we may publish images from this event on our website(s) and on our social media accounts.