Medical device standards have changed. If you develop or sell medical devices, you need to be aware of these changes because they could make a massive impact on the future of your business.
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Medical devices must meet certain mandated standards before they are granted FDA approval and can be released on the market.
Medical hardware safety and performance is addressed in the IEC 60601 series of technical standards. In this interview, DornerWorks Senior Electrical Engineer and Electrical Design Architect Ben Algera answers a few questions about the standard:
0:15 – What is subject to IEC 60601?
1:12 – How does IEC 60601 affect your approach to a project?
2:04 – How do you mitigate risk in medical hardware?
Medical device software must meet certain mandated standards before the product it runs on can be granted approval.
Life cycle requirements for the development of medical software and software within medical devices is specified in the IEC 62304 standard. In this interview, DornerWorks Chief IoT Engineer Greg Nowak answers a few questions about the standard:
0:15 – What is subject to IEC 62304?
1:45 – How does IEC 62304 affect your approach to a project?
3:55 – How do you mitigate risk in medical software?
Products that do not meet the updated medical device hardware standard will be pulled from operation. This can negatively impact your business, but it doesn’t have to.
If you have any concerns that your products may not meet the updated requirements in this standard, we can help you develop a plan to put regulatory conformance worries aside and focus on your product design.
Schedule a meeting with us today. We can help you ensure your products meet the necessary standards and protect your business from unnecessary losses.
In the meantime, get started with this development series and learn how innovators like you are overcoming these challenges.