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About Us
Medical Device RA/QA Services
ISO 13485 Certification Consulting
FDA 21 CFR 820 Implementation
EU MDR (2017/745) Compliance
QMS Compliance for Software
Computer Software Validation (CSV) / Assurance (CSA)
MDSAP Internal Audits
FDA Mock Audits
FDA 483 Mitigation
CAPA & Root Cause Analysis
Critical Supplier Audits
Risk Management
GxMP GAMP
FDA 21 CFR Part 11 Compliance
Remote Medical Device Audits
Auditor Training
Medical Device QMS Auditing
Remediation Service
Cybersecurity
Contact Us
Request Quote
Resources
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GxMP GAMP
GxMP GAMP