Basic info
Industry
medical equipment manufacturing
Sectors
FDA 510 K
Regulatory Compliance
Gap Analyses
Audit
Quality Assurance
Person Responsible for Regulatory Compliance
ISO 13485:2016
Medical Device Clinical Evaluation
Consulting
IVDR (EU 2017/746)
PMS (Post Market Surveillance)
Medical Device Quality Assurance
Training
In House Training
PSUR (Periodic Safety Update Report)
Medical Device
Medical Device Software Validation
MDR (EU 2017/745)
Technical File Preparation
Risk Management
93/42/EEC
Date founded
2018