PMS Plans and Reports 

Proactive and reactive Post Market Surveillance planning and execution 

Post Market Surveillance for medical devices is a key regulatory requirement for maintenance of global market access. This requires a proactive and reactive approach for a detailed assessment of the benefit/risk ratio.

Article 84 to Article 88 of the EU MDR, the Medical Device Coordination Group (MDCG), and FDA’s 21 CFR Part 822 emphasize to manufacturers the importance of implementing regulatory compliant Post Market Surveillance Systems which are also associated with existing ISOs. 

At Aolete, we design Post Market Surveillance Plans with with assurance of delivering on the following objectives: 

• Affirm clinical safety and performance based on device claims, indications and intended purpose

• Relate to safety and performance endpoints in relations to thresholds for the expected outcomes.

• Have a potential to estimate the key risks and Benefits based on device clinical claims

• Define a criterion for methods of data collection, analysis, presentation and evaluation to meet key safety and performance indicators

• Account for the state of the art in medicine for the device’s treatment landscape

We then develop Post Market Surveillance with focus on: 

• Detailed analysis of data from all sources pertaining to Post Market Surveillance Planning

• Scope all PMS activities in relation to the plan

• Summaries and conclusions that show a clear Benefit/Risk Profile for the device