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
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.
DSI is a great company to work with!
- Director of Operations and Quality