SCHWEIZERISCHE VEREINIGUNG FÜR QUALITÄTS- UND MANAGEMENTSYSTEME
Bernstrasse 103
3052 ZOLLIKOFEN
Country : Switzerland
Phone : +41:31:910 35 35
Fax : +41:31:910 35 45
Email : headoffice@sqs.ch
Notified Body number : 1250
Website : SCHWEIZERISCHE VEREINIGUNG FÜR QUALITÄTS- UND MANAGEMENTSYSTEME
Medical Device Accreditation
MD 0101: Non-active devices for anesthesis, emergency and intensive care
MD 0102: Non-active devices for injection, infusion, transfusion and dialysis
MD 0103: Non-active orthopedic and rehabilitation devices
MD 0104: Non-active Devices with measuring function
MD 0105: Non-active ophthalmologic devices
MD 0106: Non-active instruments
MD 0108: Non-active medical devices for disinfecting, cleaning, rinsing
MD 0202: Non-active orthopedic implants
MD 0203: Non-active functional implants
MD 0204: Non-active soft tissue implants
MD 0301: Bandages and wound dressings
MD 0302: Suture material and clamps
MD 0303: Other material for wound care
MD 0401: Non-active dental equipment and instruments
MD 0402: Dental Materials
MD 0403: Dental Implants
MD 1101: Devices for exracorporeal circulation, infusion and hemopheresis
MD 1102: Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anesthesia
MD 1103: Devices for stimulation or inhibition
MD 1104: Active surgical devices
MD 1105: Active ophthalmologic devices
MD 1106: Active dental devices
MD 1107: Active devices for disinfection and sterilisation
MD 1108: Active rehabilitation Devices and active prostheses
MD 1201: Imaging devices utilising ionizing radiation
MD 1202: Imaging devices utilising non-ionizing radiation
MD 1404: Devices for (extracorporeal) shock-wave therapy (lithripsy)
Horizontal Technical Competence
MDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
MDS 7006: Medical devices in sterile condition
ANNEXES
MDD ANNEX II: Full Quality Assurance
MDD ANNEX V: Production Quality Assurance
MDD ANNEX VI: Product Quality Assurance
IVD Medical Device Accreditation
IVD 0309: Device for self-diagnosis for measurement of blood sugar
ANNEXES
ANNEX IV: Full Quality Assurance System
ANNEX VII: Production Quality Assurance