Qserve Group is pleased to announce that Valerie Bennet has joined Qserve to further expand its capabilities in supporting the medical device industries worldwide.
Valerie is part of Qserve’s US Regulatory Affairs and Clinical teams providing strategic perspectives from a manufacturer’s point of view with a focus on clinical affairs. Her areas of expertise include regulatory strategy and submissions, quality and risk management implementations/review, and project management.
With over 25 years’ experience, Valerie has a reputation for listening, focusing, and delivering according to her client’s requirements. She was given an opportunity to work in the medical device industry over 6 years ago and has experience working for multi-national corporations and start up organizations. As a regulatory professional with medical writing experience, Valerie has utilized her strategic thinking to develop solutions to assist clients with clinical and regulatory requirements. Valerie has multiple industry experience with successful transitions that include the defense, telecommunications, and transportation industries.
Valerie’s core competences include clinical data collection strategy for the EU, training for Usability, Post Market Surveillance, Risk Analysis, and Clinical Evaluations in the EU and China, management of Clinical Evaluation remediation projects for both MDD and MDR and strategizing US FDA 510K applications.
Currently, her focus is on designing and implementing Clinical Evaluation strategies for CE certifications for a variety of medical devices (class I, IIa, IIb and class III).
Valerie has a BS degree in Electrical Engineering for Florida Atlantic University and has been a Project Management Professional (PMP) since 2004.
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 its 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.