 Sue Spencer BSI Healthcare Global Head of IVD Visit Website |
Sue Spencer has twenty-six years of experience in the IVD industry, and has held various positions in R&D, Manufacturing, and Quality Assurance. She joined BSI in 2009 as Head of IVD, where she has developed a full scope Notified Body that can provide a responsive IVD service to clients world-wide.
Previously, Sue worked for a UK Notified Body as a Technical and Operations Manager covering both the Medical Device and IVD Directives during the introduction of both the Medical Device and IVD Directives, and as a consultant before joining a large global diagnostic manufacturer as Manager for International Quality Systems and Risk Management for the Division. She is an experienced instructor and regularly delivers interactive training courses with accelerated learning objectives. Want more information? Download IVD Materials at http://www.bsiamerica.com/IVDdoc |
IVD Regulations and Standards Q&A
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Will the label on an IVD product need to change to designate compliance with the new IVD Directive regulations?Answered February 16th, 2012 by Expert:The labelling may change to meet new essential requirements and may now include a Notified Body number to identify that a conformity route requiring a Notified Body has now been applied. However, if neither of these are affected by the new regulations, there may be no obvious change to the labels.
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