Audit
Clarity, confidence and compliance across processes, quality systems and technical documentation.
REGULATORY AUDITS FOR MEDICAL DEVICES AND IVDs
MediQuasar provides internal, external and documentation audits for companies operating in medical devices, advanced cosmetics and foods for special medical purposes. Audits help verify processes, quality systems and documentation, supporting compliance with MDR/IVDR, ISO 13485 and other applicable standards.
We support organisations throughout all phases: planning, execution, nonconformity management and process improvement.
AUDIT TYPES
INTERNAL AUDIT
Review of processes, the quality management system and internal documentation to ensure compliance with regulatory requirements and readiness for external audits. Audits are also available for suppliers.
EXTERNAL AUDIT
Support in preparing for and accompanying audits conducted by third parties or Notified Bodies, including immediate nonconformity handling and supplier qualification.
A structured review of technical documentation, GSPR, CER, BER, UER, PMS/PMCF and alignment with standards and guidance, including gap analysis and practical recommendations.
What MediQuasar provides during an audit
- Full audit planning
- Checklists based on MDR/IVDR and ISO standards
- Identification of nonconformities, observations and improvement opportunities
- CAPA and corrective action support
- Training for involved personnel
- Clear, audit-ready reporting
- Assistance during external audits
- Supply chain verification
- Technical documentation review
- Ongoing preparation for periodic audits
Medical devices
Advanced cosmetics
Industrial processes
CE marking
THE AUDIT PATHWAY
1.
Preliminary assessment and objective setting →
2.
Document collection and checklist preparation →
3.
Audit execution (on-site / remote) →
4.
Nonconformity identification →
5.
Final Report →
6.
Improvement support and follow-up
Want to make your organisation audit-ready?
Get in touch to schedule a focused audit—or a programme of periodic reviews—to strengthen compliance, safety and operational efficiency.
MediQuasar s.r.l.
Via Vittorio Veneto, 11,
41032 Cavezzo MO, Italia
Phone. +39 393 2859 8580
Mail info@mediquasar.it
Vat no. 04162970364