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Address
920 Aspen Court, Boston
Clinic Hours:
9:00am – 5:00pm (Mon-Fri)
Clinic Number
(857)-200-1031
Emergencies:
(617)-350-2714
Menu
920 Aspen Court, Boston
9:00am – 5:00pm (Mon-Fri)
(857)-200-1031
(617)-350-2714
Post-Market Surveillance (PMS) is a continuous, active and systemic process of gathering, recording and analysis of relevant data on the quality, performance and safety of a medical device (MD) (including in vitro diagnostics devices – IVDs) throughout its entire lifetime. The PMS in conducted within the framework of a PMS plan (PMSP). Results and conclusions of a PMS are summarized in a Post-Market Surveillance Report (PMSR). Additionally, the PMSR describes any preventive and corrective action taken as a result of incidents related to the medical device. PMSP and PMSR are part of the technical documentation of PMS for devices.
According to the European Union (EU) Medical Devices Regulation (MDR) (MDR 2017/745), manufacturers of class I MDs are required to prepare a PMSR, to update when necessary, and to make available to the competent authority upon request. Similarly, manufacturers of class A and B IVDs are required to prepare, update, and make available the PMSR for their IVD according to the In Vitro Diagnostic Regulation (IVDR 2017/746).
We offer support to manufacturers and sponsors to perform clinical investigations and PMS for their devices compliant with the current regulations. This includes assistance in the planning of the clinical investigation, preparation of the PMSP and the PMSR.
We offer support to manufacturers and sponsors to perform clinical investigations and PMS for their devices compliant with the current regulations. This includes assistance in the planning of the clinical investigation, preparation of the PMSP and the PMSR.
We offer support to manufacturers and sponsors to perform clinical investigations and PMS for their devices compliant with the current regulations. This includes assistance in the planning of the clinical investigation, preparation of the PMSP and the PMSR.