Quality & Compliance

We take product design and manufacturing compliance seriously and adhere to strict, industry-recognized standards. Starting with a conceptual sketch, each product design is methodically documented with evidence of conformity to ISO 13485 and FDA 21 CFR 820 protocols. This “Technical File” is maintained throughout the entire product lifecycle management, including all product design validation critiques to ensure projects remain in alignment with our stringent quality systems. Our commitment to rigorous quality assurance has allowed us to become registered by authorities such as the Japan JPAL and Hong Kong Medical Device Control Office.