Kapstone Medical

Kapstone Manufacturing Expands and Achieves ISO 13485 Certification

Kapstone Medical is proud to announce the expansion of its manufacturing solutions company, Kapstone Manufacturing.


Charlotte, NC -- (ReleaseWire) -- 07/07/2020 --Kapstone Medical is proud to announce the expansion of its manufacturing solutions company, Kapstone Manufacturing. As an ISO-certified and FDA-registered firm, Kapstone Manufacturing extends its capacity to provide full-service, single-source solutions to medical device companies, from prototyping to pilot production to final production and commercialization.

"By formalizing and strengthening manufacturing solutions that our team has been facilitating for years," said John Kapitan, CEO, "Kapstone Manufacturing is able to complete a full suite of offerings for our medical device customers."

Integrating early and seamlessly with the Kapstone Medical staff, the Kapstone Manufacturing team is positioned to help medical device companies commercialize their product, including services for prototyping, production, assembly, sterilization, packaging, and more. Extensive experience and visibility into the entire process allows Kapstone to provide value in minimizing risk, staying on budget and moving quickly to market. Leveraging a global network of suppliers and exhaustive list of materials, the company is prepared to launch any type of product.

"Along with Kapstone Manufacturing, we're proud to announce that Kapstone Medical has also achieved ISO 13485:2016 certification," said Mike Burgan, COO of Kapstone. "This is truly unique to have two such companies in the same family earn this certification and it represents our commitment to quality and excellence."

Visit the Kapstone Manufacturing website: www.kapstonemanufacturing.com

Kapstone Manufacturing Differentiators

Global Network of Suppliers
With specialized capabilities located around the world, the company offers nearly every manufacturing method available and an optimal combination of quality, price, and lead time.

The company offers a broad range of material and production methods, which allows it to customize solutions for customers' unique needs without being tied to a certain technology.

Integrated Approach
Manufacturing solutions are just one component of the full-service Kapstone offering. By integrating disciplines of design, materials science, quality, regulatory, manufacturing, operations, and logistics, the company decreases risk and increases efficiencies.

About Kapstone Medical and Kapstone Manufacturing
Kapstone Medical is a full-service, single-source medical device consulting firm that provides comprehensive, multidisciplinary assistance in Quality Assurance, Regulatory Affairs, Product Development, and Manufacturing Solutions. Kapstone Manufacturing, a separate company in the Kapstone family, is a global contract manufacturer of medical devices. Both companies' medical device experts help its customers navigate a cost-effective, top quality, and expedited route to market.

For more information, please contact:
Justin Rowland
Director of Business Development