FDA Medical Device Manufacturing
The Challenge
A leading international supplier of medical devices, including custom therapeutic garments for lymphedema and venous disease, wanted to expand their product line to offer standard size products. They needed a partner that was able to provide strict quality controls and meet FDA requirements as an FDA registered medical device contractor. It was important that they had a consistent and repeatable manufacturing process to create standard size garments.
Medical-Grade Quality
Our established ISO compliant quality control system provided them with the documentation needed for an FDA regulated medical device contractor. Our automated, programmable sewing capabilities [link to contract sewing] provided the consistency and repeatability necessary for their standard sizes. We were easily able to accommodate their volume requirements as they continued to scale and launch the products to their distributors.
Focus on Your Core Competency by Outsourcing Manufacturing
Being able to trust us with the mechanics of manufacturing, they were free to concentrate on their strengths of design, marketing, and distribution. This has allowed their business to grow exponentially over recent years.