{"id":12744,"date":"2023-06-09T12:05:16","date_gmt":"2023-06-09T16:05:16","guid":{"rendered":"https:\/\/www.spartasystems.com\/?post_type=resources&p=12744"},"modified":"2023-06-26T12:12:53","modified_gmt":"2023-06-26T16:12:53","slug":"integrated-risk-management-qms","status":"publish","type":"resources","link":"https:\/\/www.spartasystems.com\/resources\/integrated-risk-management-qms\/","title":{"rendered":"Integrated Risk Management: Go Beyond Compliance"},"content":{"rendered":"\n

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\u00a0medical devices<\/a><\/strong>\u00a0are designed and manufactured while also increasing the diversity in usage environments of those same products.<\/p>\n\n\n\n

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<\/a> must successfully integrate with the quality management system.<\/p>\n\n\n\n

Let’s consider the benefits of integrating quality risk management with the quality management system (QMS)<\/a>.<\/p>\n\n\n\n

Why Risk Management is Getting Harder<\/h3>\n\n\n\n

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.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

A Better Approach to Risk Management<\/h3>\n\n\n\n

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\u2019s 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.<\/p>\n\n\n\n

An\u00a0integrated risk management<\/strong>\u00a0approach will:<\/p>\n\n\n\n