European medical device manufacturers and stakeholders can benefit from local production and world-class ISO 13485 quality.

Americhem Healthcare, a globally recognized developer and manufacturer of custom color masterbatch, functional additives, engineered compounds and performance technologies, has intensified its efforts in Europe to support material selection and medical device development.

“We’re furthering our ‘global reach, regional focus’ by extending Americhem’s capabilities to meet increasing European healthcare industry demand for high quality polymer materials. We stand at the forefront of medical device market trends, healthcare application innovation and sustainable solutions,” said Barto DuPlessis, Vice President and General Manager, Europe.

“Our masterbatch and compounding excellence for advanced surgical instrumentation, robotic-assisted surgery (RAS), drug delivery, catheters, hearing aids and more lines up perfectly with the needs of the European healthcare market.”

Americhem is introducing ColorRx® compounds and masterbatch in a variety of standard colors and base resins to the European market to help OEMs and their molders kick start their device development. Custom color matching and development is also part of the offering and Americhem will be with stakeholders every step of their application journey.

Some of the features include:

ColorRx® polymers will be produced in one of three ISO 13485 and cGMP compliant facilities throughout the world, ensuring the highest standards of quality and reliability. The formulations are locked and undergo rigorous biocompatibility testing, providing peace of mind for healthcare applications.
ColorRx® manufacturing includes two state-of-the-art clean compounding facilities, guaranteeing the purity and quality of the polymers. This is crucial for maintaining the integrity of medical devices and ensuring patient safety.
With a robust process change management system and notice of change protocols, ColorRx® ensures consistency and reliability in every batch. This minimizes risks and ensures that your medical devices meet stringent regulatory requirements.
ColorRx® offers global supply and formulations that are RoHS and REACH compliant. This ensures that your medical devices can be used worldwide, meeting international standards and regulations.
ColorRx® is committed to sustainability, offering eco-friendly formulations that reduce environmental impact. This aligns with the growing demand for sustainable healthcare solutions.

An aging patient population, miniaturization of devices, increased and evolving regulatory scrutiny, demand for sustainable products and growth in emerging markets‒just to name a few‒are fueling efforts to help customers stay ahead of the curve.

“Our capabilities in polymeric engineering allow our customers to design their cutting-edge devices to meet the rigor of the medical environment through precise material selection, custom compound design, and color harmony,” added DuPlessis.

Americhem Healthcare was purposefully created to fully support all phases from a product designer’s vision to prototyping to the full launch of a medical device with the material quality and consistency imperative in the medical industry. For more information, visit www.Americhem.com.

About Americhem

Americhem is an innovative, technology-driven leader in the global polymer industry. Its foundation is built around delivering Performance, Solutions and Trust through close collaboration with customers. All of the company's products are backed by complete technical support that ensures quality, reliability and value. Americhem operates 10 manufacturing plants and maintains sales offices throughout the world. Learn more at americhem.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240924490603/en/

Bill Urban
Healthcare Market Manager
Americhem
burban@americhem.com

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