17th of June, Qserve Group, the leading global medical device and in vitro diagnostics consultancy, training, and CRO company, is welcoming Sue Spencer, further expanding its capabilities to support the IVD industry worldwide. Sue is the leading expert on EU IVD certification, having 35 years of IVD experience in industry and Notified Bodies.
The IVDR will impact all IVD manufacturers selling in the European Union. With Sue Spencer joining as Head of IVD, Qserve is ready to support its clients with preparing for the fundamental changes imposed by the new European IVD Regulation (IVDR). The classification of IVD’s will be risk-based leading to major classification changes compared to the current system. As a consequence, over 80% of IVD manufacturers selling in the EU will require assessment of technical documentation and their quality system by a Notified Body and CE certification.
Sue Spencer has a long career in the IVD field. After starting out as a scientist at a hospital, she stepped into the IVD industry and worked at Serono, Anagen, and Abbott Diagnostics. In addition to her industry experience, she spent a large part of her career in leading positions at Notified Bodies (LRQA, BSI, and UL). At BSI, Sue established their designation under the IVD Directive and made BSI a leading IVD Notified Body. At UL she was Global Service Line Director covering both medical devices and IVD. As an IVD technical expert, she chaired the IVD NB group within NBMED and represented the NBs at the European Commission’s IVD Technical Group and is speaking regularly at conferences. These roles have given her extended knowledge about the intentions behind and the interpretations of the new European IVD Regulation.
Sue Spencer: “I am excited to take this new step. As part of the Qserve team, I will be able to support manufacturers worldwide with a pragmatic, result-driven approach. Worldwide, Qserve is the leading consultancy partner for MDR/IVDR implementation projects and provides MDR and IVDR training worldwide. I am glad I can add my experience and expertise to train, educate, and support manufacturers on the IVD regulations. I’m looking forward to the opportunity to share my experience.
Qserve’s IVD team has an international footprint with members in the US, China, and European offices working together to serve manufacturers locally and globally. Our support ranges from strategy pathways for market access in the EU, US, China, and RoW, to creating technical files, setting up a QMS, to clinical support.
Jan van Lochem (CEO): “I am very pleased that Sue Spencer joins our Qserve team. Sue has such a wealth of regulatory, clinical and management experience through many years in industry as well as at Notified Bodies. Her experience dealing with the EU-IVDR discussions that took place over recent years will give us the advantage to go the extra mile for our customers.
The addition of Sue will further strengthen our services, especially in IVD, to support our customers in the increasingly challenging regulatory environment while building Qserve’s presence as the leading regulatory, quality and clinical partner for the MedTech industry”.
About Qserve Group
Qserve’s mission is to support all medical device and in-vitro diagnostics manufacturers with a practical approach, translating existing regulations to understandable requirements. We serve to guide manufacturers in gaining and maintaining compliance as well as conducting clinical studies as a CRO to ensure safe and quality devices in the most streamlined way possible.
Qserve’s global team combines their regulatory and clinical knowledge and experience in the medical device industry, sharing more than 900 years’ worth of combined expertise in the medical field. Having teams in the EU, USA, and China provides a global footprint for global regulatory, clinical, CRO and quality services.