A Software Developer's Journey Through MDR Transition

Obtaining Medical Device Regulation certification poses significant challenges for a medical device software development company. The MDR’s rigorous requirements demand a deep understanding of regulatory standards, such as classification rules, clinical evaluation, and post-market surveillance, which can be especially complex for software classified as a medical device.  One of the primary challenges lies in aligning the software development lifecycle (SDLC) with MDR standards, particularly ensuring that processes meet the stringent requirements of ISO 13485 and IEC 62304. Documenting every aspect of design, risk management, and testing can be resource-intensive, especially for smaller companies with limited regulatory expertise.  Another hurdle is clinical evaluation, which requires demonstrating safety and performance through robust data. For software, this often means gathering extensive clinical evidence and addressing the challenges of usability and cybersecurity risks.