At ThermoFit, we operate under internationally recognized quality and regulatory standards to ensure reliability, safety, and consistency across all our products.

Our thermoplastic materials are supported by verified technical documentation aligned with the European Medical Device Regulation (EU) 2017/745, confirming compliance with international requirements for medical-grade thermoplastic products . These products are classified as Class I medical devices (non-sterile) and are manufactured under controlled processes that ensure consistent performance.

Additionally, our manufacturing partners operate under a certified ISO 13485:2016 Quality Management System, the global standard for medical device manufacturing, ensuring strict quality control, traceability, and process consistency.

Our products are also registered within the U.S. FDA Establishment Registration & Device Listing system, reinforcing transparency and alignment with U.S. regulatory frameworks.

Furthermore, production is backed by official medical device manufacturing certifications issued health authorities, confirming that the products meet the necessary requirements for manufacturing and commercialization within regulated environments .

What this means for you

Our commitment

While ThermoFit is a U.S.-based company, our focus is to deliver products that meet global quality expectations, ensuring that professionals can work with confidence, precision, and consistency in every application.