AURA MedTeQ
Regulatory and quality support
Structured review of the requirements, processes and evidence that matter to your device.
Define the evidence needed
Support can include EU MDR or IVDR pathway scoping, technical-documentation structure, GSPR mapping, risk-management file review, and PMS or PMCF planning. Each project is matched to the device, role and applicable requirements.
Build workable quality processes
Review controlled documents, supplier qualification, CAPA records, management-review inputs and audit preparation. Support references ISO 13485 and ISO 14971 without reproducing licensed standards or representing certification.
A useful delivery package
- Scope and reviewed-document list
- Findings with evidence references and priorities
- Action plan with owners and dependencies
- Review meeting and agreed revision round
Make the next step specific.
Describe the device, market and question. Contact you can keep and share.