Summa Design provides contract services to Fortune 100 companies, as well as small startups. We offer a broad spectrum of services to the medical device community, but are not limited to one field or specialty. Our engineers and managers have an unsurpassed depth of experience in medical device design, development, prototyping, quality systems, regulatory issues, and transfer to manufacturing.
We can assist you in any phase of development... from concept, design, and prototype engineering to testing, verification, and quality assurance. In addition, we recently moved to a new facility that will allow us to expand our capabilities into low volume production runs.
Our regulatory and quality experts will help design your quality system or audit your existing system for FDA and international compliance. We can also help with preparation and review of your 510(k) applications prior to submittal.
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