Bridgemedica achieves ISO 13485:2003 Certification
for Medical Device Design and Manufacturing
Certification Reflects Company’s Commitment
to High Quality Standards and Stringent Compliance Guidelines
to High Quality Standards and Stringent Compliance Guidelines
Walpole, MA—July 30, 2008
Bridgemedica, LLC, a company providing high value innovative concept-to-market services in design, development engineering, sourcing, assembly and distribution of innovative new medical devices, announced today that it has achieved ISO 13485:2003 certification through auditor BSI Management Systems.
“The ISO certification process was a major business initiative of our company and reflects the organization’s commitment to designing and manufacturing high quality products for the medical device market,” commented Robert E. Pelletier, President of Bridgemedica.
“Achieving this important objective sets Bridgemedica apart from many of our competitors and ensures our clients a quality outcome while helping them achieve their business initiatives.”
Bridgemedica, located in a 20,00 square foot facility in Walpole Massachusetts is a team of medical device professionals with the capabilities to bring expertise to the entire development process. Whether working with customers to commercialize new technologies or improve existing devices, Bridgemedica innovates new solutions that allow for improved care and better economics for both OEMs and patients. The company’s core competencies include fully integrated services in design, development engineering as well as sourcing, U.S. assembly, packaging and distribution.
BSI Management Systems, a leading quality management systems registrar with a reputation for holding its customers to the highest standard, was selected by Bridgemedica as its notified body for ISO 13485:2003 certification. A BSI auditor examined Bridgemedica’s quality system, including the product development process, materials documentation practices, and measurement systems for tracking customer satisfaction and supplier performances.
ISO 13485:2003 applies to organizations involved with the product design, engineering and contract manufacturing services for medical device customers. The Bridgemedica facility, which includes a 1,500 square foot class 10,000 clean room will accommodate assembly and packaging of electro/mechanical capital medical devices as well as assembly and packaging of sterile and non-sterile medical disposables. The ISO certification process ensures ongoing compliance as companies are externally audited every twelve months and then required to recertify every four 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
“The ISO certification process was a major business initiative of our company and reflects the organization’s commitment to designing and manufacturing high quality products for the medical device market,” commented Robert E. Pelletier, President of Bridgemedica.
“Achieving this important objective sets Bridgemedica apart from many of our competitors and ensures our clients a quality outcome while helping them achieve their business initiatives.”
Bridgemedica, located in a 20,00 square foot facility in Walpole Massachusetts is a team of medical device professionals with the capabilities to bring expertise to the entire development process. Whether working with customers to commercialize new technologies or improve existing devices, Bridgemedica innovates new solutions that allow for improved care and better economics for both OEMs and patients. The company’s core competencies include fully integrated services in design, development engineering as well as sourcing, U.S. assembly, packaging and distribution.
BSI Management Systems, a leading quality management systems registrar with a reputation for holding its customers to the highest standard, was selected by Bridgemedica as its notified body for ISO 13485:2003 certification. A BSI auditor examined Bridgemedica’s quality system, including the product development process, materials documentation practices, and measurement systems for tracking customer satisfaction and supplier performances.
ISO 13485:2003 applies to organizations involved with the product design, engineering and contract manufacturing services for medical device customers. The Bridgemedica facility, which includes a 1,500 square foot class 10,000 clean room will accommodate assembly and packaging of electro/mechanical capital medical devices as well as assembly and packaging of sterile and non-sterile medical disposables. The ISO certification process ensures ongoing compliance as companies are externally audited every twelve months and then required to recertify every four 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
