Post-market surveillance of medical devices is among the weakest areas in the medical device sector. Manufacturers can easily underestimate requirements due to imprecisely defined legislation and guidelines. It is not uncommon that manufacturers fail to capture meaningful post-market data and encounter difficulties in drawing correct interpretation of their device performance.
QFI has planned and implemented post-market surveillance, post-Market clinical follow-up and device tracking for medical device manufacturers and distributors for several years. With over 50 years of cumulated practical experience in medical device governmental agencies, supporting manufacturers as authorised representative, managing wide variety of activities ranging from corrections and removals, product recall, notification to treat or warn, safety alerts, etc, we have achieved considerable, un-rivalled know-how, aptitude and service in supporting clients seeking practical and practicable post-market experience monitoring programmes.
We have created programmes that enable clients to fulfil American and European legislation as well as many other international jurisdictions, transform guidelines into effective practices and where contracted, even allow clients to outsource such operations to us. We will also help clients to comply with the new Medical Device Regulation, which puts significant emphasis on post-market surveillance.
We ensure connection between clients’ processes for market surveillance, etc and rick management work, derive and transform data reciprocally efficiently and effectively.
We also offer detailed, critical market surveys including analysis and full reports.