• Quality Management System procedures development in compliance with ISO 13485, EU MDR, FDA 21 CFR Part 820 (QSR) and TGA regulations
• Pre- and post-market regulatory compliance for start-up MedTechs
• All risk classes medical devices including active implantables, Artificial Intelligence (AI) in Software as a Medical Device (SaMD)
• Regulatory strategy in key markets: EU, UK, US, Australia
• Technical File preparation
• Regulatory submissions to EU Notified Body, FDA 510(k)s and PMAs, inclusion in the TGA ARTG
• Unique Device Identification (UDI)
• Risk management
• Clinical evaluation
• Advertising of medical devices
• Training sessions tailored to customer needs – category of devices, target market(s)
• Regulatory and quality workshops