Medical Device Compliance with IEC 62304 and ISO 14971

With increasing market pressure to develop complex, high quality medical products as fast as possible, compliance with medical devices regulations and standards is becoming more and more of a challenge. Medical device developers worldwide are facing the problem of maintaining and enhancing product safety, reliability, and compliance with standards such as IEC 62304 (lifecycle processes) and ISO 14971 (risk management) among others while reducing development times. Implementing mature processes to achieve continuous and automated compliance helps reduce time to market, and means a significant competitive advantage for medical device companies.

Watch our webinar recording to learn how to manage compliance in the fast-paced development of medical devices, including topics such as:

• Maintaining quality while reducing medical tech development time
• Mature process control and traceability
• Risk management per ISO 14971 & compliance with IEC 62304

The webinar’s agenda:

1. Basics of IEC 62304
2. Basics of ISO 14971
3. Process control & traceability
4. Setting up processes according to normative requirements of these standards
5. Live demo