Post-Market Services
We provide comprehensive post-market surveillance solutions
Implementing a proactive post-market surveillance (PMS) system is crucial for monitoring and proving the continuous safety and performance of medical devices in compliance with the MDR.
A comprehensive PMS System, in compliance with article 83 of the MDR, involves systematic data collection, analysis, and reporting activities that are integrated into the manufacturer's quality management system.
The goal of PMS is to ensure that any device-related issues with an impact on safety or performance are promptly identified and properly addressed, ensuring continuous compliance with MDR requirements.
We offer turn-key clinical development services
Proactive device monitoring.
We work closely with our customers, recognising that post-market activities are critical throughout the entire medical devices lifecycle, helping, with our expertise to properly implement and optimizing your PMS System to seamlessly meet MDR requirements.
Leveraging years of experience, we provide comprehensive support in the following areas:
Optimization of PMS System procedures
Development of PMS plans
Preparation of Post Market Surveillance Reports (PMS Reports) and Periodic Safety Update Reports (PSURs)
Fulfilment of Post-Market Clinical Follow-up requirements (PMCF Plan and PMCF Report), including the turnkey conduction of PMCF studies
Implementation of 1Survey+ for Real World Data Collections
Drafting and update of Clinical Development Plans (CDPs)
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