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