Stay Compliant: Achieving IEC 62304 Compliance For Software Medical Devices
Stay Compliant: Achieving IEC 62304 Compliance for Software Medical Devices
The software as a medical device (SaMD) market is expected to reach US$86 Billion by 2027 from US$18 Billion in 2019. The future of the health industry is propelled by software medical devices and digital health. The growth comes with challenges for companies and regulators to ensure that the software devices are safe and effective. The “IEC 62304: Medical Device Software - Software Life-cycle Processes” standard is playing a vital role in conjunction with ISO 13485 and ISO 14971 to enable safe and effective software medical devices development. The IEC 62304 provides a framework of life cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software.
This session is going to discuss.
- Importance of the IEC 62304
- Overview and major clauses
- How companies can achieve compliance and stay compliant
- Standards complementing IEC 62304
Kamala K Nanjundeshaiah is a quality and regulatory professional with in-depth knowledge and broad experience. She is proficient in implantable devices, software medical devices, cloud-based and digital health products. She is also specialized in product compliance to IEC 62304, IEC 82304, IEC 62366 and cybersecurity standards. Prior to the quality and regulatory, she worked on development of embedded systems and have a US patent for a safety design solution.
She is currently working on software medical device design quality assurance and regulatory compliance at Varian Medical Systems (Siemens Healthineers company). She is an active member of ASQ, and certified quality engineer & auditor. She is involved with ASQ serving in the leadership committee, speaker at ASQ WCQI, regional and section events and published articles.
The webinar is free but does require registration. Follow the link below to register. If you have questions or would like more information please contact Bob Shanks at firstname.lastname@example.org