Transitioning Medical Device Production

At times, existing manufacturing supplier relationships can become challenging. Production issues such as poor communication, product nonconformance, or unreliable delivery can put unnecessary strain on product fulfillment goals. Innovative medical device OEMs need the support of a manufacturer that can reliably achieve all production goals and scale to meet growth in demand in a compliant fashion with high velocity.

Transitioning Medical Device Manufacturing to Cogmedix

Transitioning medical device manufacturing to a new contract manufacturer can be a difficult process, resulting in excess costs for the purchase of new equipment, shipping materials, tooling fixtures, programming, and more. Incomplete documentation and miscommunication of tribal knowledge can further challenge a successful transition. Our goal is to make the switch as easy and painless as possible for you.

At Cogmedix, our team of engineers and program managers has the knowledge, experience and proper processes in place to ensure that all relevant information is carried over and stringently documented. Through our proprietary Scaled Product Launch™ (SPL) process, a dedicated team will work with you and your current manufacturing supplier (whether in-house or external) to ensure all relevant information is obtained, documented and detailed for a successful transition to Cogmedix.

Flexible FDA-Compliant Manufacturing Services

medical device manufacturing process documentationCogmedix is highly focused on regulatory compliance and all our manufacturing procedures and facilities are fully compliant with 21 CFR 820 and ISO 13485. Our Caring Associates have extensive experience in medical device manufacturing, and are passionate about providing an exceptional customer experience. Ongoing competency based training provides elevated skill levels and enhanced productivity.

Located outside of Boston, Cogmedix has access to highly skilled technological resources as well as the Providence, RI, and Worcester and Boston, MA airports. This makes it easy for customers to collaborate with our personnel. While other manufacturing companies have minimum thresholds for production, Cogmedix does not. Our system of competency-based cross-training ensures that we can provide excellent coverage to customers both large and small and offer the flexibility of a well-trained staff that can move from one program to another with ease while maintaining compliance standards.

Comprehensive Supply Chain Management

Whether you prefer to maintain relationships with existing suppliers or work with new ones, Cogmedix is able to accommodate your needs. By leveraging established relationships with more than 1,000 suppliers to access materials quickly and affordably, we can maximize the profitability of a device—especially in partnership with our sister company, Columbia Tech for printed circuit board assemblies and system subassemblies.

Cogmedix values the innovative worth and positive impact on patients of every medical device we manufacture. We focus on developing lasting relationships with our clients that include a long-term vision for scalable growth. Is your current manufacturing supplier holding you back from achieving your expansion goals? Contact the medical device manufacturing experts at Cogmedix today!