BSI implements plans to expand its medical device Notified Body scope to include IVD devices

BSI, a world-class Notified Body providing regulatory and quality management reviews and product certification for medical devices, is rapidly implementing plans to expand its medical device Notified Body scope to include in vitro diagnostic (IVD) devices. BSI has appointed Sue Spencer, an IVD industry veteran, to lead what looks to be an early 2010 expansion. Spencer is focusing on the accreditation process along with creating a dynamic team of in-house experts. The new expansion will make BSI a full-service Notified Body supporting all types of devices, including medical, active implantable and IVDs.

The In Vitro Diagnostics Directive (IVDD) sets the requirements needed to place IVD devices on the European market. In vitro diagnostics includes all devices and kits used to test human samples in order to diagnose a medical condition. As medical science advances and technologies converge, it is essential that a Notified Body can support clients across device categories. By extending its Notified Body service to include the IVD Directive, BSI will enable customers to work with one organization for all their regulatory needs, which will, in turn, enhance efficiency, predictability and speed-to-market.

Sue Spencer has been tasked as head of IVD and will be responsible for setting up an expert, quick-response, fully accredited IVD Notified Body to serve IVD device manufacturers globally. Spencer has 24 years of experience in the IVD industry working in R&D, manufacturing, compliance, risk management and quality for a range of large and small device manufacturers. She worked as a consultant for three years and set up her own consultancy before joining Abbott Diagnostics Division where she served as manager for International Quality Systems and Risk Management. In addition, Spencer has worked as a technical and operations manager for a UK Notified Body during the development of the IVD and Medical Device Directive.

Spencer already has brought together a team of IVD experts with more than 60 years combined experience in the industry. These experts have worked on all aspects of the product life cycle, including R&D, manufacturing and quality. BSI will continue to add to its in-house IVD team of experts in the coming months, which will enable BSI to provide a fast, responsive service to customers.

“I am thrilled to join BSI and lead the company’s new IVD group,” said Sue Spencer. “By bringing together an unmatched team of product and technology experts in house, BSI has demonstrated its commitment to the success of its IVD Notified Body and to meeting the demands of the IVD marketplace. The collaborative environment at BSI also ensures that as we encounter more complex devices that often cross device categories, we will be able to leverage experts at all levels of the organization and across Notified Body teams to deliver the highest quality, most efficient and effective reviews possible. As the medical device industry evolves, I am excited to be part of a team that is truly setting the standard.”