QUALITY
Coatings
Achieving the optimal coating for a medical device only begins with the initial chemical formulation. Coating formulations require refinement during the optimization phase, and continued testing and analysis of coated devices through verification and validation. Testing and analysis should continue throughout the production lifecycle.
Surmodics leverages rigorous tools and methods to meet or exceed increasing regulatory requirements. These tests include chemical characterization, coating thickness via scanning electron microscope (SEM), visualization of coating uniformity, lubricity and durability using standard industry methods, and biocompatibility testing of individual components and device/coating combinations.
Surmodics Certifications
Surmodics’ facilities are ISO 13485:2016 and ISO 9001:2015 certified for the design, development, production, and distribution of drug delivery, in vitro diagnostics, and surface modification technologies, components, and products for medical applications.
ISO 13485 2026 Expiry
Accredited Quality System
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ISO 9001 2026 Expiry
Full Quality Assurance System
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