TitanBody Certifications

Device Test Reports & Certifications

MD CE

TitanBody™’s MD CE certification confirms that our medical devices meet the European Union’s requirements for safety, performance, and regulatory compliance.This designation reflects a rigorous, independent review of our technical documentation, quality management systems, and clinical evidence. It enables our products to be marketed within the EU while giving partners and customers confidence that TitanBody™ operates to internationally recognized standards.

MSDS

TitanBody™ maintains comprehensive Material Safety Data Sheets to support the safe handling, transport, storage, and disposal of our products. Each MSDS is prepared in alignment with globally recognized regulatory frameworks and provides detailed guidance on composition, hazards, first aid measures, firefighting procedures, accidental release response, exposure controls, and environmental considerations. Documentation is reviewed and updated as needed to reflect the most current safety information.

PAHs

TitanBody™ is committed to monitoring and controlling polycyclic aromatic hydrocarbons, commonly known as PAHs, within our materials and finished products. We work with qualified laboratories to conduct testing in accordance with applicable international regulations and guidance. This process helps verify that PAH concentrations remain within permitted limits and supports our broader commitment to product safety, regulatory compliance, and responsible manufacturing.

POPs

TitanBody™ is committed to controlling and restricting persistent organic pollutants, or POPs, in our materials and finished products. We evaluate substances in accordance with applicable international regulations and recognized testing methodologies. Through supplier qualification, material oversight, and independent verification where appropriate, we work to ensure that restricted POPs are not present above permitted thresholds.

REACH

TitanBody™ is committed to compliance with the European Union’s REACH Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals. We work closely with our suppliers to monitor substances contained in our materials and to ensure that any chemicals of concern are identified, communicated, and managed in accordance with regulatory obligations. Where applicable, we support registration, authorization, and restriction requirements and maintain processes to track updates to the Candidate List of Substances of Very High Concern.

RED CE

TitanBody™ complies with the requirements of the European Union’s Radio Equipment Directive for applicable products incorporating radio functionality. Conformity under RED CE demonstrates that essential standards for safety, electromagnetic compatibility, and effective use of the radio spectrum have been satisfied. Assessment activities include structured testing, technical documentation review, and ongoing manufacturing controls designed to maintain compliance throughout the product lifecycle.

RoHS

TitanBody™ complies with the European Union’s RoHS Directive governing the restriction of hazardous substances in electrical and electronic equipment. We maintain processes with our suppliers to monitor material composition and to help ensure that restricted substances such as lead, mercury, cadmium, hexavalent chromium, and certain flame retardants are not present above permitted thresholds. Verification activities may include documentation review, material declarations, and analytical testing where appropriate.

WEEE

TitanBody™ supports compliance with the European Union’s Waste Electrical and Electronic Equipment Directive for the responsible end-of-life management of electrical and electronic equipment. We work with authorized partners and established collection and recovery systems to promote proper treatment, recycling, and environmentally sound disposal. Our approach helps reduce waste, conserve resources, and ensure that products placed on the market meet applicable producer obligations.