Cardic Instruments

Competent Authority Support and Standards Regulatory Compliance for International Regulatory Authorities. MDR Competent Authority Communication and Contact Point.

Drawing up and keeping up to date of the technical documentation and the EU declaration of conformity and compliance for registered medical devices. Post-market surveillance obligations in accordance with Article 10(10) of MDR. Reporting obligations referred to in Articles 87 to 91 whereas needed. Quality management system Regulatory Compliance Practices.