Market Surveillance is part of the everyday regulatory life.
A test according to the standard XY is a Polaroid, a snapshot of the current state of your product or a partial aspect of your performance promise.
As soon as the declaration of conformity (DoC) is signed, the processes of market surveillance begin, i.e. Post Market Surveillance (PMS) and Post Market Clinical Follow Up (PMCF).
Your own complaint evaluations and customer feedback are not ignored. Regulatory affairs managers have no choice but to regularly go through the relevant databases. Larger companies can use automated or semi-automated retrieval. For many others, this solution is out of the question due to the high set-up and operating costs. An alternative is subscribing to norm tickers and other newsletters that need to be evaluated. We also offer a standards segment that can at least make your search for standards a little easier, as we are edit it with our clientele in mind. In response to multiple customer requests, we have now included the evaluation of the ISO database.
Whichever way you go, the first step is defined process, the plan:
- Which steps are to be carried out – when and how?
- Check and determine whether the PMS and PMCF can perhaps be done in one step.
- Define search locations and search criteria so that auditors can understand your work and approve it.
However, if there is a lack of time or know-how, there is still the option of outsourcing. In addition to the newsletter mentioned above, we also offer our help in this area. Feel free to contact us.