ISO 9001 QMS Certification Consulting
Coach companies in establishing ISO 9001:2015-compliant QMS including document system, process optimization and internal audits as a foundation for medical device-specific certifications.
ISO 13485 QMS Certification Consulting
ISO 13485:2016 medical device QMS establishment, documentation, personnel training and third-party audit coaching covering design, production and risk management.
MDSAP Certification Consulting
Medical Device Single Audit Program (MDSAP) certification coaching covering regulatory requirements of USA (FDA), Canada, Australia (TGA), Brazil (ANVISA) and Japan (PMDA).
FDA QSR 820 System Consulting
Guide companies in establishing design controls, production controls and CAPA modules per FDA 21 CFR Part 820, reducing the risk of FDA warning letters.
NMPA Medical Device GMP System Consulting
Coach companies in establishing NMPA Medical Device GMP-compliant systems, covering production site compliance, quality records and registration system inspection preparation.
EU IVDR & MDR System Certification Consulting
EU MDR/IVDR technical documentation, risk management, PMS/PMCF plans, EUDAMED registration and notified body audit coaching to achieve EU market access.
Certification Implementation Path
- 01Gap Analysis
Benchmark target regulations & assess existing QMS gaps
- 02QMS Establishment
Build documentation, processes & records
- 03Internal Audit
Internal audit & corrective preventive actions (CAPA)
- 04Certification Audit Support
Third-party / notified body on-site audit
- 05QMS Certification
Remediation closure & certificate issuance
- 06Ongoing QMS Maintenance
Surveillance audit & continual improvement
Factory Audit Support Services
On-site factory audit support across North America, Europe, South America, and Africa, led by experienced compliance experts to strengthen audit readiness and response.
From QMS Setup to Certification — Full Support
Share your target certifications and current QMS status for a tailored gap analysis and implementation roadmap.