Forum Plastics Obtains FDA Registration

Forum is committed to supporting product development, design, mold construction, validation and sustaining production for the medical and life science industries. As an engineering-based company, we offer highly skilled precision manufacturing capabilities and a steadfast focus on operational efficiency and design optimization through utilization of the latest innovative technologies.

Continually focused on providing the highest level of engineering, program management, and operational performance to support its clients’ most challenging products and applications, the organization continues to broaden its capabilities and services to support the medical device industry.

As a result, the company has chosen to register with the FDA to add value to its medical device customers and future partners. By achieving FDA registration and the associated quality parameters and compliance required, customers can be confident that Forum is aware of, respectful of and committed to supporting the development of life saving and quality of life enhancing products.

“Committing to FDA registration is supported by the fact that we are already ISO 13485: 2016 certified, meaning we have the necessary processes in place and are experienced with diligent record maintenance, full bilateral traceability procedures, staff training, product segregation and maintaining the highest level of quality standards,” noted Forum’s Director of Regulatory Affairs, Jose Mosello. “Extending that to comprehensive regulatory reporting requirements and associated training modules reinforces our already stringent operational methodology. Forum has a history of focusing on innovation, and we are fortunate that our teams are accustomed to successfully integrating new programs and initiatives.”

Forum is strategically focused on expanding their vertical integration and full system assembly platforms to support medical device clientele. From an industry standpoint, FDA Registration (Title 21 CRF 807.3) adds a level of confidence that the company is able and committed to meeting the requirements to provide more fully integrated assemblies and complex devices in response to increasing market needs. With the addition of FDA registration, and the expansion of their Class VII cleanroom assembly and vertical integration services, Forum provides an enhanced value proposition through vendor reduction, reduced lead-times and a competitive total landed cost via full solution provider leverage.

“FDA registration is an exciting next step for us,” said Khristine Carroll, Forum’s Vice President of Business Development “Given the quality standards and partnership commitment that we are offering to the medical industry, and as we continue to expand our technology-based capabilities and life science focused market initiatives, we are laser focused on responding to the evolving needs and considerations of our customers. This registration will support our mission to provide a more comprehensive and fully integrated solution in response to industry requests and market needs.”

To learn more about Forum’s capabilities and how the company can assist you with your medical device product development and sustaining production, contact sales@forummolding.com.