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