Medical equipment classified as Class III are more risky and require rigorous regulatory approval. How can QA make sure that during the design and development stages the device satisfies these improved safety standards?
For Class III medical devices, which come with higher risks and stricter regulations, QA has a huge role in making sure safety standards are met early on. During the design and development stages, QA can help by doing thorough risk assessments, keeping an eye on design controls, and constantly checking that everything lines up with the regulatory requirements. By staying involved throughout the process, running internal audits, and testing the device under different conditions, QA can make sure the device meets safety standards before it even gets to the approval stage.
