The international medical device industry has seen tremendous growth, which has driven innovation for complex medical devices that have broadened the treatments available to patients. These innovations have increased the complexity of how medical devices are designed and manufactured while also increasing the diversity in usage environments of those same products.
To reduce harm to patients and users, proactively detect signals and trends, and continuously improve the quality and safety of medical devices through real-world evidence, quality risk management must successfully integrate with the quality management system.
Let’s consider the benefits of integrating quality risk management with the quality management system (QMS).
Why Risk Management is Getting Harder
Regulations are bringing more scrutiny from regulators on the risk management processes for medical devices and combination products. The European Union Medical Device Regulation (EU MDR) and ISO 14971:2019 requirements are bringing the full burden of risk management to medical devices and combination products.
Risk management in the new era is a big undertaking that spans all lifecycles of product development and means tracking practically every system and process in your enterprise, from product planning, design, and changes to manufacturing activities and more through to post-market surveillance.
A Better Approach to Risk Management
To be effective, all your risk management efforts must be interconnected. Information must be handed off between departments in a way that keeps complexity from leading to confusion. These teams include personnel from quality, regulatory affairs, clinical affairs and many more who speak about similar topics in different ways. It’s a lot to ask of cross-functional teams from every part of your organization to coordinate so much data frequently enough to be useful when they are working in siloes.
An integrated risk management approach will:
- Reduce harm to patients using your products
- Detect signals and identify trends for effective root cause analysis and decision making
- Improve quality and safety continuously
- Ensure acceptable quality
- Resolve process and product deviations and nonconformances quickly
- Expedite approvals and market authorization
- Comply with standards and regulations
Transform Your Risk Management Process
Over the years, the constantly evolving expectations of risk management have resulted in many manufacturers developing complex, ineffective risk management processes. These changes span over three decades and include the European Directives, ISO 14971-1:1998, ISO 14971:2000 and more. The EU MDR and ISO 14971:2019 have added to the burden of manufacturers staying on top of changing regulatory expectations for medical device risk management.
Compliance with the EU MDR and ISO 14971:2019 from planning to production and post-product information collection requirements will take a lot of resources and will fail to deliver high quality for those relying on outdated risk management methods.
Manual risk management methods are not good enough anymore—they consume resources, slow down decision making, and don’t deliver the quality improvement and risk reduction that organizations need to compete.
Are you ready to take your risk management process to the next level?
Download our white paper, “A Data-Driven Approach to Quality Risk Management,” to learn how to take a data-driven approach to risk management.