House of MDR provides QMS services, audits, and training fully compliant with ISO 13485 and EU MDR.
House of MDR offers internal audits of your system to show compliance with the ISO 13485 and
MDR.
Are you aware of your mandatory obligations as a manufacturer, importer or distributor ensuring devices are safe and effective, complying with MDR? These obligations cover the entire lifecycle of your device, from its design and manufacturing through to post-market surveillance and user information provision.
We at House of MDR can establish your followed obligations, keep you up to date and report as well implement the changes into your QMS.
House of MDR provides marketing material inspection services including
Medical device advertising must comply with technical documentation, intended purpose, and MDR as well local national regulations—regardless of format or channel. The PRRC must ensure that all promotional materials align with the technical documentation and intended use. A documented review process must be part of yours QMS.
Do you need specific MDR training? We can build a training package that suits your needs. There are numerous topics. We open-up complex and difficult issues in a practical and understandable way.
ISO 13485 requires documented proof that all personnel, including management and staff, have the competence, training, and experience needed to perform their tasks related to medical device quality, ensuring they understand QMS policies, procedures, and device-specific requirements.
