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Quality is an important part of our competitiveness

The medical device industry is highly regulated and certifications are required for marketing authorizations. The EU has MDR (Medical Device Regulation) in place, specifying the roles and responsibilities of the medical device supply chain. It oversees the operations and compliance of medical device manufacturers, distributors, importers and health care operators. The oversight of the EU MDR is the responsibility of several actors whose roles and responsibilities are defined in the MDR regulation. The purpose of regulation is to ensure that medical devices are safe, effective and compliant throughout the life cycle.

Some markets, such as Canada, require MDSAP (Medical Device Single Audit Program) certification for medical devices to enter the market. The MDSAP is a harmonized and international audit program for medical devices that allows the assessment of medical device manufacturers through a harmonized audit. By combining the requirements of several regulatory authorities into a single audit process, MDSAP improves regulatory efficiency and transparency, simplifies the approval process for devices and enables to market access. It speeds up the process of demonstrating compliance and improves predictability in the regulatory process. Participating countries include the United States (FDA), Canada (Health Canada), Brazil (ANVISA), Japan (PMDA and MHLW) and Australia (TGA). MDSAP audits are performed by authorized Auditing Organizations (AOs). The audit covers the regulatory requirements of the participating countries and ISO 13485. The results and reports are approved in all participating countries.

The ISO 13485 quality management system provides a framework for CE marking, and the effectiveness of the quality management system ensures successful audits and certifications. Revenio also uses the ISO 27001 quality management system in its operations.