Support for experienced or starting companies
Challenges with Notified Body, CAPA system, resources for global registration, maintenance of technical files, preparation of Clinical Evaluation Reports, PRRC, PMCF, and Risk Management.
Lack of resources and hands-on expertise for further product development and network for compliance with international regulations.
Challenges with regulatory requirements and in need of a partner that can assist with all compliance issues, from strategy to market approval.
Do you plan to obtain market access for your medical device in Europe?
Qserve supports you with the CE approval process.