Auditing Services
Auditing Services
Experienced experts for your success
- Certified lead auditors for management systems in the MedTech industry according to ISO 13485, MDSAP and ISO 27001
Core competence: software & eHealth
- Medical device software and apps
- Combination products (drug-device related)
- Electrical safety-related devices
- Plastic injection molding processes
Reliable audit results
- Audit services, such as supplier audits, internal audit program or mock audits to different medical device related standards and regulations
- Auditing service for management systems (ISO 13485 and MDSAP, ISO 27001 and US QSR 21 CFR Part 820)
- Gap assessments for MDR, IVDR, HIPAA, NIST 2
- Regular training of auditors
- All management system audits are carried out according to ISO 19011 (auditing standard)
ISO 19011 Workflow
Audit plan (scope and requirement definitions)
Audit plan agreement
Checklist preparation (dedicated to the needs)
Execution
Reporting
Follow-up
Our certified lead auditors ensure compliance with regulatory requirements and take you through each individual process step for a comprehensive understanding.