Bridgemedica, LLC, a company providing high value innovative concept-to-market services in design, development engineering, RA/QA, sourcing, cleanroom assembly and distribution of innovative new medical devices, announced today that it has achieved a broadening of scope through their ISO 13485:2003 recertification that includes “Sterilization, Packaging and Distribution” of Medical Devices.
“The broadening of scope indication for Sterilization, Packaging and Distribution of Medical Devices is a need that our customers have been asking for and one that we are very pleased to now offer,” commented Robert E. Pelletier, President of Bridgemedica. “Achieving this objective continues to broaden the single source offering provided by Bridgemedica, which today is so important to medical device companies when selecting an outsourcing partner. “
Bridgemedica, located in a 20,000 square foot facility in Walpole Massachusetts comprises a team of medical device professionals with the capabilities to bring expertise to the entire development and manufacturing process. Whether working with customers to commercialize new technologies or to improve existing devices, Bridgemedica innovates new solutions that allow for improved care and better economics for both the patient and medical device companies.
ISO 13485:2003 applies to organizations involved with the product design, engineering and contract manufacturing services for medical device customers. Achievement of this certification reflects Bridgemedica’s continual commitment to designing and manufacturing high quality products for the medical device market. The ISO certification process ensures ongoing compliance as companies are externally audited every twelve months and then required to recertify every three years.
Experience is our trademark. Expertise is our forte.
Bridgemedica…We get you there.
Bridgemedica provides high value innovative concept-to-supply services in design, development engineering, sourcing, assembly, packaging services and distribution specializing in capital and disposable medical devices and instruments. Bridgemedica partners with its customers helping them bridge the milestones of the medical device development process eliminating hand-offs, accelerating a product’s time to market and yielding earlier revenue realization. In addition, the company offers design control, compliance related documentation tracking, and global sourcing of components and subassemblies. Bridgemedica is located in Walpole, Massachusetts.
For more information visit www.bridgemedica.com or call 508.406.2100