Bring your medical devices to market with confidence. Techparlance delivers Spanish translation for medical device documentation—including instructions for use (IFUs), eIFUs, labeling, and regulatory submissions—that aligns with FDA, EU MDR, and Latin American regulatory frameworks.
Avoid costly rework and approval delays. We translate IFUs, packaging labels, and technical documentation into clear, accurate Spanish that meets expectations from the U.S. FDA, EMA, COFEPRIS, and other regional authorities. Our consistency ensures the same compliant language across all your submission files.
We structure IFU translations with regulatory phrasing, risk language, and layout fidelity intact. Whether your content includes electronic instructions (eIFUs) or printed leaflets, we ensure Spanish versions maintain identical section structure, terminology, and hazard labeling conventions required by authorities.
From UDI labels to sterilization indicators, we translate all packaging and device claims into compliant Spanish. Our linguists work in alignment with ISO 15223‑1, ISO 20417, and relevant symbol standards to prevent submission queries or product recalls.
Each device family follows a unified terminology database shared between technical files, IFUs, and risk management documentation (per ISO 14971). This consistency demonstrates control during audits and shortens the approval cycle for multilingual regulatory portfolios.
For connected devices and hospital systems, we translate software UIs, on‑screen instructions, and error messages following the same controlled vocabulary as your IFU and labeling content. This integration prevents misalignment between documentation and digital interfaces.
