IBRATSA was founded in 2019 by Dr. Felistas Mashinya with a mission is to provide QMS Conformity Assessments and related Training to the Medical Device Technology Industry. Through its training services, IBRATSA is committed to improving customer knowledge on conformity compliance to “ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes” as well as Requirements from the South African Health Products Regulatory Authority.
The scope of certification (Technical areas) for our company which are based on the IAF MD 9: 2017 includes Invitro Diagnostic Medical Devices, Sterilization Methods for Medical Devices and Parts and Services as detailed below:
Invitro Diagnostic Medical Devices
1) In Vitro Diagnostic (IVD) Instruments and software.
2) Reagents and reagent products, Calibrators and control materials for Clinical Chemistry, Immunochemistry (Immunology), Haematology, Haemostasis, Immunohematology, Microbiology, Infectious Immunology, Histology (Cytology) and Genetic testing
3) IVD Medical Devices other than specified above.
Sterilization Methods for Medical Devices
1) Moist heat
2) Aseptic processing
3) Ethylene oxide gas sterilization (EOG)
4) Radiation sterilization (e.g. gamma, x-ray, electron beam)
5) Sterilization methods other than specified above.
Parts and Services
1) Raw materials
2) Distribution services
3) Transportation
Company’s Keywords:
invitro diagnostic devices & sterilization methods for medical devices
3
medical devices
2019
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