Medical Device Regulation Overview
ObjectivesIrish 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.
Content includesCompared 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.
Who should attendQuality 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.
Athlone Sheraton Hotel., Westmeath
21-22 May 2019