Tag: IEC 60601-1 Compliance

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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How to Structure a Medical Device Company

How to Structure a New Medical Device Business

There’s More to Being a Medical Device Business than IP and R&D An emerging medical device business tends to focus their energy on product development and R&D. This is understandable because medical device founders are often first experienced innovators. As innovators, there’s a natural affinity to maintain a continued focus on product development and maturation....
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Understand how the FDA uses the IEC 62304

IEC 62304 Safety Requirements FDA medical device recalls are on the rise. An increasingly active FDA, coupled with the rise in software components for medical devices is adding up to new challenges for manufacturers. Given this reality, it’s important to understand how the FDA uses the IEC 62304, an international standard developed that, among other things,...
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