Sagentia: Medical Device Software Development Needs 'Risk Compass' for the Digital Age
Summary
CAMBRIDGE, England, Feb. 12, 2019 /PRNewswire/ -- The complex relationship between opportunity and risk in the connected world poses unprecedented challenges for medical device manufacturers, according to software specialists at product development consultancy Sagentia . Upfront software decisions have a critical bearing on both product efficacy and the likelihood of achieving regulatory approval. And it looks at software security guidance from the US Food and Drug Administration and the Association for the Advancement of Medical Instrumentation. "Medical device development has to keep pace with the connected world, but decisions need to be underpinned by a high level of awareness," Paulo continues. "With a solid understanding of the technology and regulatory landscape, backed by robust processes, the benefits of the connected digital world can be brought to medical devices, without compromising on patient safety.