About
Medical Device Registration, CE MDR, MDD, IVDD, IVDR, MDSAP, ISO 13485, Quality Management System, Technical Documentations, Clinical Evaluation, Risk Management, Usability, Biocompatibility Evaluation.
Technologies
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Keywords
medical devicemedical equipment manufacturingconformity assessmentregulatory documentationregulatory affairsproduct registrationmedical device certificationsoftware as a medical device (samd)consultingce markingservicesmedical device registrationaudits and inspectionsgovernmentproduct testing coordinationglobal market entryeudamedpost-market surveillancemdr transitioniso 13485ukca markmedical equipment and supplies manufacturingregulatory consultingaustralia tgaudi implementationb2bregulatory strategy for medical deviceseu mdrregulatory updatesauthorized representative
Company Information
- Employees3
- Founded2013
Location
109 Ridgemont Dr, Melbourne, Victoria, Australia, 3806