Medical device development is a complex process, with a critical element focusing on risk management. The consequences of not managing risk properly can be catastrophic.
Currently, risk management (and overall product) data is often managed in Excel and/or Word, which can quickly become overwhelming with the sheer amount and complexity of data. Not only do medical device manufacturers have to manage and align this data, they also need to ensure they are meeting applicable standards and laws. How can medical device manufacturers better apply standards and regulations in their risk management process?
Standards-Driven vs. Reality-Driven Risk
Risk management for medical device development is dictated by ISO 14971 as well as ISO 24971, IEC 60812, and IEC 62366. They include buzzwords such as hazards, sequence of events, harms, hazardous situations, severity, probabilities, and more. However, in practice, the risk standards often fall short of the reality of risk management for medical device development. The standards completely ignore the concept of conducting Failure Modes and Effects Analysis and fail to mention the techniques that can help meet these standards. Companies are left creating their own processes for risk management that may or may not fully meet the standards.
The Need for Flexibility
Companies need the ability to model their development the way they want since the standards do not dictate a particular process. At Cognition, we have developed a new Risk Module for our Cockpit Enterprise solution to support ISO 14971 implementation with the flexibility to support existing processes at individual medical device companies, making it easier to address risk and deliver products to market.
Access Why Flexibility and Support Matter for Effective Risk Management in Medical Device Development On Demand Now!