TÜV NORD Scandinavia Medical Notified Body AB
Accreditation no: 10597
- Postal and visiting address:
- Isafjordsgatan 22, plan 5, 164 40 Kista · Show on map
Certification of management system, SS-EN ISO/IEC 17021-1:2015
Latest decision date: 2024-03-22
| Kluster | Kravspecifikation | Näringsgren/process/produkt | Delprodukt |
|---|---|---|---|
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | Active (non-implantable) medical devices other than specified above | Active (non-implantable) medical devices other than specified above |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | Devices for radiation therapy and thermo therapy | Devices for (extracorporal) shockwave therapy (lithotripsy) |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | Devices for radiation therapy and thermo therapy | Devices for hyperthermia/hypothermia |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | Devices for radiation therapy and thermo therapy | Devices utilizing ionizing radiation |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | Devices for radiation therapy and thermo therapy | Devices utilizing non-ionizing radiation |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | General active medical devices | Active dental devices |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | General active medical devices | Active devices for disinfection and sterilization |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | General active medical devices | Active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | General active medical devices | Active devices for patient positioning and transport |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | General active medical devices | Active ophthalmologic devices |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | General active medical devices | Active rehabilitation devices and active prostheses |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | General active medical devices | Active surgical devices |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | General active medical devices | Devices for extra-corporal circulation, infusion and haemopheresis |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | General active medical devices | Devices for stimulation or inhibition |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | General active medical devices | Medical gas supply systems and parts thereof |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | General active medical devices | Respiratory devices, devices incl.hyperbaric chambers for oxygen therapy; inhalation anesthesia |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | General active medical devices | Software, including software design for medical devices |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | Monitoring devices | Monitoring devices of non-vital physiological parameters |
| Active Medical Devices (Non-Implantable) | SS-EN ISO 13485:2016 | Monitoring devices | Monitoring devices of vital physiological parameters |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | Devices for wound care | Bandages and wound dressings |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | Devices for wound care | Other medical devices for wound care |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | Devices for wound care | Suture material and clamps |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | General non-active, non-implantable medical devices | Non-active devices for anesthesia, emergency and intensive care |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | General non-active, non-implantable medical devices | Non-active devices for injection, infusion, transfusion and dialysis |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | General non-active, non-implantable medical devices | Non-active instruments |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | General non-active, non-implantable medical devices | Non-active medical devices for disinfecting, cleaning, rinsing |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | General non-active, non-implantable medical devices | Non-active medical devices with measuring function |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | General non-active, non-implantable medical devices | Non-active orthopedic and rehabilitation devices |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | Non-active dental devices and Accessories | Dental implants |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | Non-active dental devices and Accessories | Dental materials |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | Non-active dental devices and Accessories | Non-active dental devices/equipment and instruments |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | Non-active implants | Non-active cardiovascular implants |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | Non-active implants | Non-active functional implants |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | Non-active implants | Non-active orthopedic implants |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | Non-active implants | Non-active soft tissue implants |
| Non-active Medical Devices | SS-EN ISO 13485:2016 | Non-active medical devices other than specified above | Non-active medical devices other than specified above |
| Parts or services | SS-EN ISO 13485:2016 | Components | - |
| Parts or services | SS-EN ISO 13485:2016 | Distribution services | - |
| Parts or services | SS-EN ISO 13485:2016 | Maintenance services | - |
| Parts or services | SS-EN ISO 13485:2016 | Other services | - |
| Parts or services | SS-EN ISO 13485:2016 | Raw materials | - |
| Parts or services | SS-EN ISO 13485:2016 | Subassemblies | - |
| Parts or services | SS-EN ISO 13485:2016 | Transportation services | - |
| Sterilization Method for Medical Devices | SS-EN ISO 13485:2016 | Aseptic processing | - |
| Sterilization Method for Medical Devices | SS-EN ISO 13485:2016 | Ethylene oxide gas sterilization (EOG) | - |
| Sterilization Method for Medical Devices | SS-EN ISO 13485:2016 | Low temperature steam and formaldehyde sterilization | - |
| Sterilization Method for Medical Devices | SS-EN ISO 13485:2016 | Moist heat | - |
| Sterilization Method for Medical Devices | SS-EN ISO 13485:2016 | Radiation sterilization (e.g. gamma, X-ray, electron beam) | - |
| Sterilization Method for Medical Devices | SS-EN ISO 13485:2016 | Sterilization method other than specified above | - |
| Sterilization Method for Medical Devices | SS-EN ISO 13485:2016 | Sterilization with hydrogen peroxide | - |
| Sterilization Method for Medical Devices | SS-EN ISO 13485:2016 | Thermic sterilization with dry heat | - |
- Accreditation for SS standard also means accreditation for the corresponding edition of European and international standard.
Regulations
- IAF MD 1:2023
- IAF Mandatory Document for the Audit and Certification of a Management System Operated by a Multi-Site Organization
- IAF MD 11:2023
- IAF Mandatory Document for the Application of ISO/IEC 17021-1 for Audits of Integrated Management Systems
- IAF MD 2:2023
- IAF Mandatory Document for the Transfer of Accredited Certification of Management Systems
- IAF MD 23:2023
- Control of Entities Operating on Behalf of Accredited Management Systems Certification Bodies
- IAF MD 28:2023
- IAF Mandatory Document for the Upload and Maintenance of Data on IAF Database
- IAF MD 4:2025
- IAF Mandatory Document for the Use of Information and Communication Technology (ICT) for Auditing/Assessment Purposes
- IAF MD 9:2023
- Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485)
- STAFS 2020:1
- Swedacs föreskrifter och allmänna råd om ackreditering