REGULATORY & QUALITY CONSULTING
- 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