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Study Day: Regulatory - EU Medical Device Regulations, the Upcoming Changes
PrintMedical Device Study Day
£200.00 excl VAT – £240.00 inc VAT
About this course
Our Study Days
Our study days enable you to witness the very best in the industry coming together and working with you to resolve the most current concerns relating to specific topics in the field of medical device quality assurance and regulatory affairs. For example, our regulatory study days feature industry experts with at least 20 years’ practical experience, coupled with the necessary authority to present their considered opinions, but this is countered by similar experienced regulatory professionals. We effectively get the ‘truth’ from all sides.
About This Study Day
NSF-DBA invites you to participate in an in-depth analysis of the proposed new regulation for medical devices and active implantables, due to take effect in 2015.
The proposed new regulation is 194 pages, as opposed to 60 for the MDD and 35 for the AIMDD, and so is a formidable document to absorb and digest. This study day is your opportunity to come and listen to the best in the industry debate and explain how it will work in practice.
This important and far-reaching new legislation is the result of long discussions between the commission and stakeholders in the 27 member states. It aims to address the perceived weaknesses of the directives currently in force, as highlighted by the PIP and MoM issues, so some of the new requirements can be seen as severe.
The proposed regulation is based on a lifecycle approach, from design through clinical trials to post-market issues, and the study day will follow this sequence in examining the major issues and changes.
