Basic info
Industry
medical equipment manufacturing
Sectors
Technical Documentation
Medical Device
EN 62366
Experts
IVDR (In Vitro Diagnostic regulations) 2017/746
Process Management
MDR (Medical Device Regulation ) 2017/745
Training
MDD (Medical Device Directive) 93/42/EC
IVD (In Vitro Diagnostic) EU Directive 98/79/EC
CAPA
Document Control
Quality
Test and Measurement
Regulatory specialist
ISO 14971
ISO 13485
IEC 62304
Medical Device Industry
Regulatory and Quality compliance
Quality Management System
Consulting
IEC 62366-1
Advice
Quality Assurance
Lead Auditer
Date founded
2016