FDA registered. Hydromer is ISO 9001:2015 certified with TUV Rheinland of North America. ISO 13485:2016 is certified with BSI.

FDA registered. Hydromer is ISO 9001:2015 certified with TUV Rheinland of North America. ISO 13485:2016 is certified with BSI.

About Medical Device Coating

Deep expertise to accelerate customers around the world

Hydromer’s adept support and service results from our strong expertise in manufacturing and medical devices. Our knowledge of medical device manufacturing and coating technologies, as well as a thorough understanding of FDA, ISO, and other medical regulations around the world, enables us to provide the highest level of technical and commercial support to customers. We assist our clients with strategic regulatory planning, submissions, and access to device master files. Our expertise can help accelerate FDA and international regulatory processes to help our clients bring their products to market faster.

Hydromer® Coatings for Medical Devices Help Your Strategic Positioning

Hydromer’s excellence in medical device coating technology translates into smarter, more efficient working environments for our clients. With over 40 years of experience in developing world class products, medical device companies of all sizes look to us to for their coating needs, allowing them the flexibility to focus on their core business areas.

Hydromer® Coatings for Medical Devices

Whether you’re a start-up, mid-size, or large multi-national conglomerate

Hydromer can support your coating needs along the entire value chain based on your capabilities and requirements.

How we can help:

Our Commitment

We make our customer’s performance requirements, business targets and production volume goals our own. Our customer-focused team of Ph.D. chemists, knowledgeable executives, and skilled personnel will advise and guide you to ensure you find the best approach for your specific projects. As an FDA registered medical device company with ISO 13485:2016 certification, Hydromer’s laboratory facilities can run feasibility and validation tests on devices to solidify proof-of-concept and ascertain any coating limits. Additionally, we retain a working knowledge of prototype development.

We look forward to being your strategic partner on your next project.

Look to Hydromer for medical coatings that have a legendary 40-year track record of use on a variety of metallic, polymeric, and ceramic substrates, as well as on multitude of devices.

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