As a Biomedical Engineer at MedTech Solutions, my role involves ensuring regulatory compliance of our innovative medical devices. Specifically, I was part of a team that handled the launch of a novel heart valve implant.
In this project, we strictly adhered to regulatory guidelines from FDA’s QSR (Quality System Regulation) and the ISO 13485 medical device standard. To ensure thorough document control and effective risk management, we used a Quality Management System software. It helped in streamlining our processes, maintaining regulatory documentation, and conducting regular internal audits.
Ultimately, our regulatory diligence paid off when we successfully passed our FDA inspection, allowing for a smooth product launch. This experience reinforced the vital role of stringent regulatory adherence, not just for product approval, but also for ensuring the safety and efficacy of medical devices.