Regulatory Compliance is a necessary part of medical product design. We can assist you in gaining the necessary regulatory approvals for your medical product.​ Additionally, we routinely conducts full pre-submission reviews of products to the IEC 60601 and IEC 61010 standards. These reviews help to ensure full awareness of any deficiencies prior to a regulatory submission. Design Solutions can also address design deficiencies and walk clients through formal agency testing at a certified laboratory.  

REGULATORY Compliance technical skill set

• Evaluation and mitigation of design risks
• EMC compliance
• Safety compliance (IEC 60601)
• Software gap analysis (IEC 62304)
• Failure analysis
• Creation of supporting documentation for FDA 510(k) submissions

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Our Services

A collaborative team partnership

We take pride in our extensive range of services to our clients. Our ISO 13485:2016 certified engineering design process assures our customers that we can fulfill their needs at every level of the medical device design and development process.

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DSI is a great company to work with!

- Director of Operations and Quality