- Overview
- Capabilities
- Managing Product Lifecycle
- Clinical / Initial Build
- Product Experience
- Managing Conformity Assessment
Clinical / Initial Build
MD specializes in high mix, low volume builds, typical of most medical devices. We understand that when it comes to clinical trials, there is no room for error. We recognize that quick time to market with a high quality device at a low cost is critical to success.
Building a complex, high quality product which conforms to specifications in every detail is critical. Our ISO 13485:2003 certified Quality System is uniquely structured to produce a documented and controlled build environment while being flexible to meet business and compliance goals.
Our Manufacturing and Test Engineers work closely with our skilled technicians to provide build and test documentation that provide accuracy, repeatability and traceability.
From parts procurement, prototyping, and controlled builds to verification and
shipment, our system can allow traceability of every component and every test
performed.
Our experience with medical devices has shown us that design diligence at every
phase of product development is crucial in creating a product that will
withstand the scrutiny of a PMA or 510K submittal. The CES MD team is
dedicated to producing products that we and our customers are proud to stand
behind.