Tag: FDA 510(k) Approval

Human Factors Validation

10 Things You need to know about Human Factors Validation

As medical devices become more complex, the FDA will continue to place greater emphasis on ways to improve safety and effectiveness before products are commercialized. One relatively recent method is Human Factors Engineering, also known as Usability Engineering, which is used to identify and mitigate use errors. Of course, this can place additional burdens on...
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Don’t Forget Safety Testing and the Value of Risk Management!

Establish the Safety of Your Medical Device with IEC 60601 Compliance In our experience, the most frequently forgotten aspect of medical device development and commercialization from emerging companies is establishing a safety profile of a product. While clinical data or clinical trials may be necessary for establishing safety for some products, many Class II devices...
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