Auditing
Why audits?
Audits and inspections are essential for all medical device manufacturers and other economic operators.
Meliora Compliance offers its expertise to provide second-party auditing services to its customers. These services cover on-site and remote audits.
Scope
We perform the following types of audits:
- Initial QMS assessment audits
- Internal audits
- Mock audits to verify readiness for unannounced audits
- Audits to critical subcontractors
- Pre-audits and pre-inspections before audits by regulators
- Audits to verify implementation of specific CAPAs
- For-cause pre-inspections
- Special audits to verify compliance with a specific standard/regulation
The scope of our auditing services includes the following regulatory requirements:
- ISO 13485
- EU MDR and IVDR
- US FDA QSR (21 CFR Part 820)
- MDSAP
We also support customers in the following audit-related activities:
- Creation of CAPA plans mitigating audit findings
- Representation of companies in audits/inspections by their customers, EU certification/notified bodies, MDSAP auditing organizations and US FDA
- Combination of auditing with subsequent consulting services
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