Case Study: MedQAIR achieves streamlined post-market compliance with Cleffex's MDIS platform

MedQAIR strengthens post-market compliance with Cleffex and ISO/IEC 27001:2022 certification

MedQAIR, a European Authorised Representative for medical device manufacturers, faced challenges managing post-market compliance. Their work, which required constant collaboration between various economic operators, was handled through fragmented tools like email and spreadsheets, leading to delays, manual data entry errors, and limited visibility. They partnered with Cleffex to build a centralized platform to modernize these operations.

Cleffex designed and built the MDIS platform, a secure, unified environment grounded in practical regulatory workflows. The solution provided centralized documentation, role-based permissions, and fully traceable approval processes. This resulted in reduced duplication, improved operational efficiency, and clear feedback loops for MedQAIR. The platform also achieved ISO/IEC 27001:2022 certification, validating its structured information security framework.

MedQAIR