About
Medical Device Registration, CE MDR, MDD, IVDD, IVDR, MDSAP, ISO 13485, Quality Management System, Technical Documentations, Clinical Evaluation, Risk Management, Usability, Biocompatibility Evaluation.
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Keywords
medical device
medical equipment manufacturing
conformity assessment
regulatory documentation
regulatory affairs
product registration
medical device certification
software as a medical device (samd)
consulting
ce marking
services
medical device registration
audits and inspections
government
product testing coordination
global market entry
eudamed
post-market surveillance
mdr transition
iso 13485
ukca mark
medical equipment and supplies manufacturing
regulatory consulting
australia tga
udi implementation
b2b
regulatory strategy for medical devices
eu mdr
regulatory updates
authorized representative
Company Information
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Employees 3
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Founded 2013
Location
109 Ridgemont Dr, Melbourne, Victoria, Australia, 3806