Compliance is a necessary part of medical product design. We can assist you in gaining the necessary regulatory approvals for your medical product.
Design Solutions 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.
Design Solutions 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.
Technical Skills
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Working With Us
We take pride in our range of services to our clients. Our ISO 13485 certified design process assures our customers that we can fulfill their needs at every level of the medical device design process.
DSI is a great company to work with!
- Director of Operations and Quality
