The ongoing efforts in maintaining quality and safety persist, and in some instances, become more rigorous post-product launch. Collaborating with experts in post-market surveillance before any crises arise can proactively address numerous potential issues. However, all medical device manufacturers may encounter regulatory findings. We offer assistance in adeptly navigating adverse events by identifying associated risks, updating Severity and occurrence scales, establishing trigger levels, and initiating Corrective and Preventive Actions (CAPAs). Our resources aid medical device manufacturers

and other entities involved in device distribution in adhering to FDA requirements and regulations once products are in the market. This encompasses activities such as implementing tracking systems, reporting device malfunctions, serious injuries, or fatalities, and registering establishments involved in device production or distribution. Additionally, we comply with post-market requirements and conduct studies mandated under section 522 of the act, as well as post-approval studies stipulated during the approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application.

Global Expansion Strategies of the European Union

Meeting current regulatory standards across borders demands dedicated and seasoned resources. As global harmonization progresses, devices must align with requirements wherever they are available for purchase. Wall Street Consulting Services qualified consultants ensure seamless compliance across markets worldwide.