Gyógyszerészeti és Egészségügyi Minőség- és Szervezetfejlesztési Intézet Eszközminősítő és Kórháztechnikai Igazgatóság (National Institute for Quality- and Organizational Development in Healthcare and Medicines Directorate of Device Testing and Engineering)
Diós árok 3
H-1125 Budapest
Country : Hungary
Phone : +36 1 356-1522
Fax : +36 1 375-7253
Email : cert@emki.hu
Notified Body number : 1011
Website : National Institute for Quality – Hungary
Medical Device Accreditation
MD 0101: Non-active devices for anesthesis, emergency and intensive care
ANNEXES
MDD ANNEX II: Full Quality Assurance
MDD ANNEX III: EC-Type Examination
MDD ANNEX IV: EC Verification
MDD ANNEX V: Production Quality Assurance
MDD ANNEX VI: Product Quality Assurance
Active Implantable Medical Device Accreditation
ANNEXES
ANNEX 2: Complete Quality Assurance System
ANNEX 3: EC Type-Examination
ANNEX 4: EC Verification
ANNEX 5: Production Quality Assurance
IVD Medical Device Accreditation
ANNEXES
ANNEX IV: Full Quality Assurance System
ANNEX V: EC Type-Examination
ANNEX VI: EC-Verification
ANNEX VII: Production Quality Assurance