Norwegian accreditation

Accreditation scope for

MSYS 018

DNV PRODUCT ASSURANCE AS

Postboks 116
1300 Sandvika

Telephone: +47 67 57 99 00
E-mail: infodnvpa@dnv.com
Internet: http://www.dnv.com
The certification body meets the requirements in

NS-EN ISO/IEC 17021-1:2015



Accreditation includes:
The administrative / geographical unit:
DNV PRODUCT ASSURANCE AS
Veritasveien 3
1363 Høvik



is accredited for certification of the following management system:
Standard no. And issue date
Description
Remarks
Standard no. And issue date
NS-EN ISO 13485:2016
Description
Medical devices. Quality management systems. Requirements for regulatory purposes
Remarks
Description of the scopes which are included in the accreditation:
Code
Description of the scopes which are included in the accreditation
1_1_1 Non-Activ
General non-active, nonimplantable medical devices 
1_1_2 Non-Activ
Non-active implants 
1_1_3 Non-Activ
Devices for wound care 
1_1_4 Non-Activ
Non-active dental devices and accessories 
1_1_5 Non-Activ
Non-active medical devices other than specified above 
1_2_1 Active Me
General active medical devices 
1_2_2 Active Me
Devices for imaging 
1_2_3 Active Me
Monitoring devices 
1_2_4 Active Me
Devices for radiation therapy and thermo therapy 
1_2_5 Active Me
Active (non-implantable) medical devices other than specified above 
1_4_1 In Vitro
Reagents and reagent products, calibrators and control materials for: Clinical Chemistry Immunochemistry (Immunology) Haematology/Haemostasis/Im munohematology Microbiology Infectious Immunology Histology/Cytology Genetic Testing 
1_4_2 In Vitro
In Vitro Diagnostic Instruments and software 
1_4_3 In Vitro
IVD medical devices other than specified above 
1_5_1 Steriliza
Ethylene oxide gas sterilization (EOG) 
1_5_2 Steriliza
Moist heat 
1_5_3 Steriliza
Aseptic processing 
1_5_4 Steriliza
Radiation sterilization (e.g. gamma, x-ray, electron beam) 
1_5_5 Steriliza
Low temperature steam and formaldehyde sterilization 
1_5_6 Steriliza
Thermic sterilization with dry heat 
1_5_7 Steriliza
Sterilization with hydrogen peroxide. 
1_5_8 Steriliza
Sterilization method other than specified above 
1_6_1 Dev Incor
Medical devices incorporating medicinal substances 
1_6_2 Dev Incor
Medical devices utilizing tissues of animal origin 
1_6_3 Dev Incor
Medical devices incorporating derivates of human blood 
1_6_4 Dev Incor
Medical devices utilizing micromechanics 
1_6_5 Dev Incor
Medical devices utilizing nanomaterials 
1_6_6 Dev Incor
Medical devices utilizing biological active coatings and/or materials or being wholly or mainly absorbed 
1_6_7 Dev Incor
Medical devices incorporating or utilizing specific substances/technologies/elements, other than specified above. 
Standard no. And issue date
Directive 2006/42/EC
Description
Annex X, Full quality assurance
Remarks
Description of the scopes which are included in the accreditation:
Code
Description of the scopes which are included in the accreditation
MOD H
CONFORMITY BASED ON FULL QUALITY ASSURANCE