Move from Documents-Based Design Control and Risk Management
Medical device companies are on the cutting-edge of advancing health care. Along with facing relentless pressures to innovate and release quality products, they also must comply with regulations and standards to remain competitive.
In this webinar, specifically designed for product and engineering teams building medical devices, you’ll learn how to move beyond the frustrations of disconnected, document-based requirement systems, streamlining your design and development and risk management processes while maintaining compliance with applicable regulations and standards.
Watch Jama Software’s Principal Consultant, Zeb Geary as the following key topics are discussed:
- Bringing systems thinking into design control and risk management activities using Jama Connect for Medical Device Development
- Aligning how you work with the development of the artifacts needed for compliance, the Designing History File (DHF) and the Risk Management file (RMF)
- Defining products and risk controls through the lens of tracing
- Using Jama Connect to align your design control and risk management processes with relevant parts of governing regulations and standards ISO 13485:2016, 21 CFR 820.30, and ISO 14971:2019