MEDICAL DEVICES
Post market Surveillance:
The work of quality and safety continues (and in some ways intensifies) after launch. Partnering with post market surveillance experts before a crisis can avert many potential issues. Yet, every medical device maker can find themselves faced with regulatory findings. We can help you successfully navigate adverse events as well. Identifying the risk associated with each event, updating the Severity and occurrence scales and setting up trigger levels and initiating CAPA’s . Our resources make Medical device manufacturers as well as other firms involved in the distribution of devices follow FDA requirements and regulations once devices are on the market. These include such things as tracking systems, reporting of device malfunctions, serious injuries or deaths, and registering the establishments where devices are produced or distributed. We also follow Postmarket requirements and perform studies required under section 522 of the act as well as post-approval studies required at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application.
European Union and Global Acquisitions
Fulfilling current regulatory requirements across borders requires dedicated and experienced resources. As global harmonization continues to develop, devices must meet requirements wherever they are sold. Qualified consultants of Fusion Life Sciences can ensure seamless compliance across markets around the world.