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’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.
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.
- For manufacturers with in-house coating capabilities, we offer tailor-made coatings that meet specific device needs.
- We offer turn-key and technology transfer solutions by providing an entire suite of coatings, coating processes, and coating equipment to jumpstart in-house production. We also offer training on the proper application, testing and validation of our coatings.
- For clients that want to outsource their device coatings, we offer contract services; devices/components may be sent to Hydromer and coated with our customized solutions, utilizing our clean room and FDA registered, ISO 13485:2016 facility. We can contract coat production quantities from small to large, suitable for clinical testing, market introduction, or commercialization.
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.
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. We look forward to being your strategic partner on your next project.