Flexan LLC, a custom contract manufacturer of medical grade silicone and thermoplastic components, and ILC Dover, a provider of single-use solutions for biopharmaceutical and pharmaceutical processing, attained ISO 13485:2016 certification for a 15,000 sq.-ft. Class 7 cleanroom facility located in Juarez, Mexico. The milestone marks a significant advancement in delivering high-quality, nearshoring solutions to medical device and pharmaceutical customers.

With increasing supply chain challenges and labor-intensive manufacturing requirements, medical device and pharmaceutical companies are increasingly turning to a nearshoring strategy for device assembly, kit packing, and custom component manufacturing, as it offers shorter transportation distance, reduced risk, and easier oversight of the production process.

The site in Juarez offers several key benefits to Flexan and ILC Dover customers including stringent quality control; increased manufacturing capacity; and strategic nearshoring location.

“This milestone underscores our mutual commitment to deliver top-tier nearshoring solutions to our valued medical device and pharmaceutical customers,” said Corey Walker, CEO of ILC Dover. “With this achievement, we are well-equipped to set new standards in the industry, by offering increased manufacturing capacity and upholding stringent quality control at our Juarez site,”