Navigating Today’s Regulatory Challenges
An NSAI Medical Devices Seminar took place on Thursday, 1st December 2011 at the Clayton Hotel, Ballybrit, Galway attended by over 50 delegates. The seminar was chaired by Kevin Mullaney
, CEO of NSAI Inc.
The seminar began with a presentations from Christine L. Ruther
entitled EN 60601-1:2005 transition: Are you ready?
Christine discussed the transition period to comply with EN 60601-1:2005 which ends 1 June 2012 and challenged the delegates as to whether they were ready to meet the new requirements. Christine highlighted the most significant changes, provided hints for addressing the risk analysis requirements of the 3rd edition, reviewed transition dates, and was available during the break times to answer specific delegate questions.
Contact Christine by email @ Christine Ruther
, Standards Officer, NSAI presented on the Current changes in standards relevant to clinical review and compliance with Medical Device Directive’s
. Chrissie outlined the changes in Clinical Assessment Standards, how to locate and keep updated on the standards you require and the importance of the Medical Devices industry to provide input into the development of standards.
Contact Chrissie by email @ Chrissie Keane
Following a networking break Dr John O'Dwyer and Dr Barbara Tucker
presented Clinical Literature and Clinical Investigation reviews for CE Mark approval
. Their presentation highlighted how best to prepare clinical data in a clinical evaluation report with the recent changes in the Medical Device Directive. John and Barbara answered questions as to the need for clinical investigation or whether a clinical literature review would be deemed adequate? The presentation discussed what a literature review should cover and how should it be prepared. Also covered was how a clinical investigation be performed and what documentation is needed to satisfy regulatory authorities?
Contact John by email @ John O'Dwyer
The seminar provided a valuable opportunity for the delegates to discuss current issues with NSAI experts and to network with other professionals in the Medical Devices industry.
NSAI Seminar Presentation Handouts
Register your interest in attending a similar seminar in 2012
The National Standards Authority of Ireland is an industry leading Notified Body providing global Medical Device approval and certification services. As Ireland’s only Notified Body, we embrace the responsibility of delivering a true customer focused, time to market services that provides our clients with a competitive edge and promotes Ireland’s position in the Global Medical Device Marketplace.