From concept to submission, we build and validate your technical documentation to meet the demands of both EU MDR/IVDR and US FDA. Regardless of device's classification or technological complexity, we ensure your technical file is complete, compliant, and ready for successful regulatory approval.
End-to-end development, management, and reporting of your Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs). We focus on strategically leveraging your existing data to substantiate clinical claims, and ensure full compliance with EU MDR and IVDR requirements within a defensible dossier.
We deliver a complete Usability Engineering File, compliant with IEC 62366-1 and FDA requirements. The deliverables include use-related risk analysis, formative usability testing to iteratively improve the design, and summative validation studies to provide objective evidence that use errors have been addressed for final design.
Conduct of biological evaluations in accordance with ISO 10993-1 and endpoint-specific standards. Our process includes a structured assessment of device characteristics, a review of existing material data, and a determination of the necessary biological endpoints. We then manage the required testing to prove biocompatibility and compile the comprehensive evaluation report for submission.
Implementation of a complete software development lifecycle according to IEC 62304 including complete technical documentation for Software as a Medical Device. We manage the end-to-end process, from requirements specification and architecture design to verification, validation, and usability engineering.