ASQ Medical Device Division Webinar - 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 p