Medical Device Regulations Overview
Irish Medtech and Skillnet in association with Meddev Solutions Limited are delighted to offer a 2-day overview and application of the Medical Device Regulation. It focuses on “how to” understand the Medical Device Regulation life cycle approach and provides relevant tools to meet the requirements within your organisation.
This course is designed to enhance the level of understanding for those actively engaging with the Medical Device Regulation.
Compared to the MDD, the MDR emphasises a shift in regulatory scrutiny. Greater importance will be placed on risk benefit, clinical data and clinical evaluations. Greater accountability is expected from all economic operators within the medical device sector. To this end there are significant additional requirements above and beyond the current legislation for all stakeholders.
This course is interactive and will use accelerated learning techniques and uses exercises to consolidate understanding. Relevant examples are used to reflect practical application of the new legislation covering multiple product types and classifications. Collaborative sessions will be used throughout the day to reinforce the concepts and give attendees experience in interpreting the regulation. Candidates will be actively engaged with emphasis on questions and group discussions to further assist their understanding.
Quality and Regulatory professionals, Auditors, Senior Management, Regulators will all benefit from this course. The content will have great value to individuals who are involved in any aspect of implementing or maintaining a EC Certificate and or Device Registration.
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.