Qserve Group

Qserve Group is a consultancy that works exclusively with manufacturers of medical devices and in-vitro diagnostics. Its services cover the regulatory, quality and clinical work required to bring medical technologies to market, with particular depth in the EU MDR and IVDR frameworks and US FDA requirements. The firm is organised around a team of consultants with engineering, scientific and clinical backgrounds.

The company's scope spans regulatory affairs and regulatory intelligence, quality assurance, clinical research and investigations - including clinical evaluations, clinical trials and IVD performance studies - and global market access. It also provides audits and assessments, regulatory submissions and strategy, contract research, and legal representation, including EU authorised representation for non-European manufacturers.

Alongside project work, Qserve Group offers interim and interim-management resourcing for regulatory and quality functions, as well as training on medical device and IVD regulatory and quality topics. The firm describes itself as a global partner with local presence, with activity concentrated on the European and United States regulatory environments.