Market observation through PMS/PMCF
As a manufacturer you are requested to pursue active market observation and develop defined post market surveillance (PMS) strategies for each product or each product family. This puts you in the position to identify and eliminate rare complications and problems across the entire product life cycle that could not be identified before placing the product on the market. Activities for post market surveillance include: processing of complaints, vigilance, surveying customers and patients, analyzing customer and patient feedback, researching scientific literature or databases of surveillance authorities for incidents and recalls, and post-market clinical follow-up (PMCF). Together we develop a strategy that will allow you to integrate this data efficiently into clinical evaluation and to consequently save a considerable amount of time and labor costs for the annual update.
Post-market clinical follow-up (PMCF) studies are so-called market observation studies conducted for medical devices with legitimate CE marking. The medical device in question must be used within its intended purpose, the study design may neither include additional invasive nor other stressful examinations. These studies serve the aim of generating further clinical data and incorporating it in the clinical evaluation report. As ISO 14155 does not differentiate between medical devices with and without CE marking, the standard is applicable to all studies/clinical investigations alike.
With our long-term study experience you can rely on us to make contact with appropriate investigators and thus ensure the best support for your study.
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"We structure your internal market observation processes and deliver ideas how you may incorporate this data into your clinical evaluation efficiently. If the results indicate that you need to conduct a PMCF study, we plan this study efficiently and ensure smooth implementation."