P10 - Qserve Consultancy B.V. (Qserve)




The Qserve Group, with offices in the Netherlands and the USA, is an independent regulatory compliance consulting firm providing regulatory compliance services to medical device companies worldwide. Qserve has a unique combination of in-house expertise, with more than 100 years experience, with a strong experience in a variety of medium- and high risk medical devices. Qserve has successfully serviced more than 200 clients since its beginning in 1998. Qserve is also providing US Agent and European Authorized Representative services

Qserve Group services and expertise include: -(high risk, border-line combination) Medical devices- technical writing, submissions & regulatory affairs: EU CE marking, FDA 510(k), IDE, PMA in the USA,  Biocompatibility & Safety management,  (pre) Clinical studies, Quality Management Systems ISO 13485 & QSR, Auditing, training and outsourcing.