Qserve Group is pleased to announce that Giovanni Di Rienzo joins Qserve to further expanding its capabilities to support the medical device industry worldwide. Giovanni is a leading expert for vascular devices, having years of experience in industry and Notified Bodies.
Jan van Lochem (CEO): “Giovanni brings a wealth of technical, clinical and regulatory experience in the cardiovascular field to Qserve.Giovanni is a leading expert with his industry background in combination with his roles within Notified Bodies BSI and TUV having led vascular review teams. Acting from the Qserve UK office, Giovanni will 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.”
Giovanni gained broad industry experience first at Sorin in heart valve research & development and later at Fresenius on design and development of bloodlines and disposables for hemodialysis equipment. From 2009 onwards he continued his career with 2 of the largest Notified Bodies. He joined BSI Notified Body as scheme manager and technical expert as part of BSI’s Vascular Devices Team. In 2015 he became Certification Lead, dealing with certification decisions, complex situations and overseeing vascular activities in Europe. In 2017 he moved to TÜV SÜD to become the global director of their Cardiovascular Focus Team.
Giovanni will join Sue Spencer in the UK, who joined Qserve recently (press release Sue).
This is a great addition to our growing global footprint. With Qserve’s expanding global footprint and a possible Brexit. The Qserve UK office will also act as ‘UK Responsible Person’ , a requirement for device manufacturers not established in the UK in case of a no-deal Brexit; More details and the grace periods per device classification can be read here (article)
Giovanni Di Rienzo: “I am looking forward to take this new step. As part of the Qserve team, I will be able to support manufacturers worldwide with a pragmatic, results-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 support manufacturers in the increasingly challenging regulatory environment. I’m looking forward to the opportunity to share my experience.
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.