Manage ISO 13485:2016 medical devices quality system with AI: regulatory documents, MDR compliance and audits generated automatically.
ISO 13485:2016 is the international standard for Quality Management Systems for medical devices. It is aligned with the MDR Regulation (EU 2017/745) and IVDR (EU 2017/746) and constitutes the reference framework for medical device manufacturers operating in the European Union. ISO 13485 certification by a notified body is the prerequisite for CE marking of devices.
Identify device class, applicable MDR requirements and regulated interested parties.
Document quality manual, procedures and records per ISO 13485 and MDR.
Implement process validation, design control and supplier management.
Manage complaints, incident reports, post-market surveillance and internal QMS audits.
Medical device manufacturers needing to certify the QMS for CE MDR/IVDR marking.
Companies distributing or importing medical devices in the EU with MDR obligations.
In vitro diagnostics manufacturers needing to comply with IVDR Regulation 2017/746.