Post Market Surveillance 

The European Medical Device Regulation (MDR) EU 2017/745 requires manufacturers to proactively monitor the risk-benefit throughout the entire device lifetime. The compliance authorities review this process with scrutiny to ensure the continued safety of all medical devices on the market.  The team of qualified and experienced experts at Aolete supports manufacturers through a vigilant PMS process and submission of quality PMS analysis to the competent authorities through the following process. 

Post-Market Surveillance Plans

Development of sufficient PMS objectives in relation to device systems’ scope. Identification of indicators and thresholds associated with the PMS objectives and defining the PMS data analysis criteria and potential methods to substantiate adequate PMS reporting. 

Post Market Surveillance Reports

As a regulatory requirement for all manufacturers of class I devices, we shall support your team to develop a PMSR that adequately addresses all requirements and conclusions to the risk-benefit to meet Notified Body expectations. 

Periodic Safety and Update Reports

The Medical Device Regulation (MDR) 2017/745 introduced a PSUR to ensure a more consistent, standardized, and systematic review of all Post-Market Surveillance (PMS) data. All manufacturers of class IIa, class IIb, and class III devices must submit a PSUR at the intervals outlined by the regulation. Our team of highly experienced experts supports our clients to develop regulatory-compliant PSURs with conclusions on frequencies and trends that remain consistent with Notified Body expectations. 

Post-Market Clinical Follow-Up Plans

As an essential component of PMS, we heavily rely on clinical literature evidence and our strategy expertise in the structured PMS process to develop MDR complaint PMCF plans with objectives that address the device PMCF needs. We support your team in developing a statistical justification of the required PMCF activities and the process to successfully execute them.

Post-Market Clinical Follow-Up Reports

We support you during the analysis of clinical evidence from the PMCF methods used with a proper description of PMCF outcomes, rationalizing why these outcomes are satisfactory in view of the residual risks to support an acceptable risk-benefit ratio.