Basic info
Industry
medical equipment manufacturing
Sectors
Medical Device
FDA
510(k)
MDD
Gap Assessment
DHFs (FDA)
AIMDD
Risk Management File
Label/Marking/Packaging Review
MDR
EMC
Test Plans
Electrical Safety
IEC 60601-1-2
ISO 14971
ISO 13485
QSRs
Technical Documentation (EU)
CMDR
Document Preparation
IEC 60601-1
IEC 60601 Series of Standards
Consulting
Standards ldentification
Date founded
1997