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 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