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