Post-market surveillance Programme
Manufacturers often underestimate post-market surveillance requirements due largely to imprecisely defined legislation and guidelines, a situation further compounded by the new Medical Device Regulations. As a result, it is not uncommon that they fail to capture meaningful post-market data and consequently can 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 extensive experience supporting manufacturers as authorised representative, managing a wide variety of activities ranging from corrections and removals, product recall, notification to treat or warn, safety alerts, etc, QFI have achieved considerable know-how and aptitude in supporting clients seeking practical post-market experience monitoring programmes.
QFI have created programmes that enable clients to fulfil American, British 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 third parties.