 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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During installation of an automated urine microscopy analyzer we find that the automat gives higher cell counts pro high power fields than seen under the microscope. The automatic count is equal to that – established with a microscope with the same magnification, but with a bigger field area. Both microscopes are with broad field objectives. Are there standards for producers of microscopes concerning the dimensions of the microscopic fields?Answered July 2nd, 2012 by Expert:The short answer is that the is no harmonized standard which addresses this issue, a harmonized standard is a standard recognized as part of the regulatory framework as a mechanism of proving compliance with the Essential Requirements of the IVD Directive. There are very few product specific standards in the IVD area, the main product specific standard is for blood glucose meters for home use and there is also a standard for media. The performance Evaluation standard EN 13612 does reference many NCCLS/CLSI documents but these are not standards in terms of the regulation.
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