About
Consulting to medical and life sciences companies, focusing on; • Product development, quality planning and execution • Regulatory strategy and execution for medical and in vitro diagnostic devices (FDA, MDD/IVDD, CMDCAS, TGA) • Software systems architecture and development, including IEC62304 Software Lifecycle compliance, processes and training • ISO14971 Risk Management compliance, process development, and training • FDA QSR and ISO13485 compliance strategy, execution and training
Keywords
medical equipment manufacturing
medical devices
hospital & health care
Company Information
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Employees 0
