Basic info
Industry
medical equipment manufacturing
business consulting and services
Sectors
9001
RA/QA Staff Augmentation
Process Validation
Data Integrity (21 CFR Part 11)
Risk Management
Training
EU MDR
CAPA
EU IVDR
Education
MDSAP
QSR quality system implementation
Quality System Audits
FDA strategic planning
ISO 14971 Risk Management
Clinical Evaluation Report
ISO 27001 Cybersecurity Audit and Implementation
Non-product Software Validation
FDA and EU Regulatory Strategy Development
SaMD
ISO 13485
Performance Evaluation Report
Lean Six Sigma
Medical Device and Pharmaceutical Training
FDA QSR Quality System Implementation
Consulting
IEC 62304 Software Validation
510(k) and PMA submissions
Medical
FDA-483 review and Warning Letter response
Curriculum Development and RA/QA Training
Date founded
1968