Basic info
Industry
medical equipment manufacturing
Sectors
Unique Device Identification (UDI) Assistance
CQA Lead Auditor Services
Medical Device Certified Safety Testing Support
FDA 21 CFR Part 820 & ISO 13485:2016 Gap Analysis
FDA 483 Remediation
Medical Device File Review
Medical Device Project Management
ISO 14971 Risk Management Support
ISO 13485:2016 QMS Development
Rehabilitation
IEC 60601 Support Services
Post Market Surveillance Support
FDA 21 CFR Part 820 Compliance Services
EU MDR 2017/745
FDA Design Controls
QMS Training for ISO 13485:2016
Health Care
ISO 13485:2016 Internal Audits and Supplier Audits
Therapeutics
CE Mark Assistance
FDA 510k Submission Support
Medical Device Consulting
ASQ
Medical Device Safety Testing Support
Date founded
2013