Norsk akkreditering

Akkrediteringsomfang for

MSYS 018

DNV GL Presafe AS

Postboks 116
1300 Sandvika

Telefon: 67 57 88 00
E-post: Malin.Wittgren@dnvgl.com
Hjemmeside: http://www.presafe.com
Sertifiseringsorganet tilfredsstiller kravene i
NS-EN ISO/IEC 17021-1



Akkrediteringen omfatter:
Den administrative/geografiske enheten:
DNV GL Presafe AS Veritasveien 3
1363 Høvik



er akkreditert for sertifisering av styringssystemer i henhold til følgende standarder:
Standard
Betegnelse
Merknad
Standard
NS-EN ISO 13485:2012
Betegnelse
Medisinsk utstyr - Systemer for kvalitetsstyring - Krav for å oppfylle regelverk
Merknad
Akkreditert sertifisering etter ovennevnte standard er begrenset til følgende bransjer:
NACE-kode
Betegnelse av bransjene som akkrediteringen omfatter
IVD10
Reagents and reagent products,calibrators and control materials for: Clinical Chemistry 
IVD11
Reagents and reagent products,calibrators and control materials for: Haematology/Haemostasis/Immunohematology 
IVD12
Reagents and reagent products,calibrators and control materials for: Microbiology 
IVD13
Reagents and reagent products,calibrators and control materials for: Infectious Immunology 
IVD14
Reagents and reagent products,calibrators and control materials for: Histology/Cytology 
IVD15
Reagents and reagent products,calibrators and control materials for: Genetic Testing 
IVD16
In Vitro Diagnostic instrument and software 
IVD17
IVD medical device other than specified above 
MD 01
General non-active, non-implantable medical devices 
MD 02
Non-active implants 
MD 02.01
Non-active cardiovascular implants 
MD 02.02
Non-active functional implants 
MD 02.03
Non-active orthopedic implants 
MD 02.04
Non-active soft tissue implants 
MD 03
Devices for wound care 
MD 04
Non-active dental devices and accessories 
MD 05
Non-active medical devices other than specified above 
MD 10
Active (non-implantable) medical devices other than specified above 
MD 11
General active medical devices 
MD 12
Devices for imaging 
MD 13
Monitoring devices 
MD 14
Devices for radiation therapy and thermo therapy 
MDS 70
Devices incorporating/utilizing specific substances/technologies 
Standard
NS-EN ISO 13485:2016
Betegnelse
Medisinsk utstyr - Systemer for kvalitetsstyring - Krav for å oppfylle regelverk
Merknad
Akkreditert sertifisering etter ovennevnte standard er begrenset til følgende bransjer:
NACE-kode
Betegnelse av bransjene som akkrediteringen omfatter
IVD10
Reagents and reagent products,calibrators and control materials for: Clinical Chemistry 
IVD11
Reagents and reagent products,calibrators and control materials for: Haematology/Haemostasis/Immunohematology 
IVD12
Reagents and reagent products,calibrators and control materials for: Microbiology 
IVD13
Reagents and reagent products,calibrators and control materials for: Infectious Immunology 
IVD14
Reagents and reagent products,calibrators and control materials for: Histology/Cytology 
IVD15
Reagents and reagent products,calibrators and control materials for: Genetic Testing 
IVD16
In Vitro Diagnostic instrument and software 
IVD17
IVD medical device other than specified above 
MD 01
General non-active, non-implantable medical devices 
MD 02
Non-active implants 
MD 03
Devices for wound care 
MD 04
Non-active dental devices and accessories 
MD 05
Non-active medical devices other than specified above 
MD 10
Active (non-implantable) medical devices other than specified above 
MD 11
General active medical devices 
MD 12
Devices for imaging 
MD 13
Monitoring devices 
MD 14
Devices for radiation therapy and thermo therapy 
MDS 70
Devices incorporating/utilizing specific substances/technologies 
Standard
ISO 13485: 2003
Betegnelse
Medical Devices - Quality management systems - Requirements for regulatory purposes
Merknad
Akkreditert sertifisering etter ovennevnte standard er begrenset til følgende bransjer:
NACE-kode
Betegnelse av bransjene som akkrediteringen omfatter
IVD10
Reagents and reagent products,calibrators and control materials for: Clinical Chemistry 
IVD11
Reagents and reagent products,calibrators and control materials for: Haematology/Haemostasis/Immunohematology 
IVD12
Reagents and reagent products,calibrators and control materials for: Microbiology 
IVD13
Reagents and reagent products,calibrators and control materials for: Infectious Immunology 
IVD14
Reagents and reagent products,calibrators and control materials for: Histology/Cytology 
IVD15
Reagents and reagent products,calibrators and control materials for: Genetic Testing 
IVD16
In Vitro Diagnostic instrument and software 
IVD17
IVD medical device other than specified above 
MD 01
General non-active, non-implantable medical devices 
MD 02
Non-active implants 
MD 03
Devices for wound care 
MD 04
Non-active dental devices and accessories 
MD 05
Non-active medical devices other than specified above 
MD 10
Active (non-implantable) medical devices other than specified above 
MD 11
General active medical devices 
MD 12
Devices for imaging 
MD 13
Monitoring devices 
MD 14
Devices for radiation therapy and thermo therapy 
MDS 70
Devices incorporating/utilizing specific substances/technologies