About
Business Consulting to Medical Device Manufacturers Assistance with ISO 13485 System Development and CE-Marking in accordance with 93/42/EEC FDA System Development and assistance with approvals Sterilisation Validation (Gamma, EtO & Steam) Plant Design for Medical Devices Clean Room Design and installation
Technologies
Microsoft Office 365ApacheMobile FriendlyCM4All
Keywords
fda approvalssterilisation validationclean air room designcemarkingplant designrisk assessmentmedical equipment and supplies manufacturingiso 17025medical device regulatory supportconsultingeto sterilizationmedical device industry supportmedical device standards consultingconstruction directiveservicesregulatory affairs supportclinical evaluationauthorized representativeproduct developmenteuropean regulatory compliancemedical device registrationmedical device certification processiso 18001iso standardsmedical industry consultingmedical device regulatory strategysterilization validationmedical industry standardssterilization validation expertsiso 14644-1
Company Information
- Employees8
- Founded1989
Location
Regent Pl, Centurion, Gauteng, South Africa, 1692
