First, we work with you to define the scope and strategic approach and agree on a timeframe, including any reporting obligations that must be met. The exchange of all necessary information takes place.
A strategy is developed to meet the requirements of Regulation (EU) 2017/745 and, if requested, ISO/TR 20416.
Together with you, we define in the PMS Plan the best methods to ensure the collection of appropriate data from reactive and proactive activities and plan all steps up to the report.
According to the defined methods and data sources we carry out the necessary research for your medical device. This step includes gathering data as well as documenting all search activities.
Based on the agreed criteria, we analyze both quantitatively and qualitatively the collected data of your products and also of similar medical devices – e.g. from regulatory safety databases, literature searches or even surveys and complaints.
Should the analyzed data show that corrective or preventive measures are necessary, or even measures in the field, we will work with you to implement these within the framework of the legal requirements. This includes compliance with any reporting deadlines.
We regularly prepare the PSUR for your Class IIa, IIb or Class III products. We are also happy to prepare the post-market surveillance report (PMSR) for your Class I devices. We ensure that the reports are available for your documentation (e.g.: the CER or the SSCP) on time.