The two companies have announced the receipt of an ISO 13485:2016 certification for their 15,000 sqft Class 7 cleanroom facility located in Juarez, Mexico
Medical grade silicone and thermoplastic manufacturer Flexan and ILC Dover have successfully attained ISO 13485:2016 certification for a 15,000 sqft Class 7 cleanroom facility located in Juarez, Mexico.
This milestone marks a significant advancement in delivering high-quality, nearshoring solutions to medical device and pharmaceutical customers.
With increasing supply chain challenges and labour-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.
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
- Corey Walker, CEO of ILC Dover
"This milestone underscores our mutual commitment to deliver top-tier nearshoring solutions to our valued medical device and pharmaceutical customers. 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," said Corey Walker, CEO of ILC Dover.
The strategically-located site in Juarez now offers several key benefits to Flexan and ILC Dover customers:
The ISO 13485:2016 certification, issued by the International Organization for Standardisation, validates rigorous standards and protocols required within a state-of-the-art designed Class 7 cleanroom, including a strictly-controlled environment that meets meticulous, exacting requirements for cleanliness and air quality in a controlled environment.
The cleanroom offers expanded kitting and assembly capabilities, which allows the companies to quickly scale production of silicone and thermoplastic medical device components and packaging, allowing for increased demand and reduced lead time.
The Juarez facility is advantageously located near the U.S. market, which helps mitigate common supply chain issues like transcontinental shipping delays and costs, and a trend among many customers looking to near-shore operations. The Juarez market also has a high density of global medical device and life science company operations, which provides access to a skilled labour force.
In 2021, ILC Dover acquired Flexan to serve a broader range of medical device and biopharmaceutical customers. Together, the companies offer custom design, manufacturing, and assembly of silicone, thermoplastic, and rubber medical device components.