BE REWARDED FOR PLAYING BY THE RULES™
MEDICAL DEVICES
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
TGA REGISTRATION
Agent services for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG)
EU Authorised Representative services
Market Access (AUS) can now provide EU Authorised Representative services through its EU-based partner company, Avoca Terrigal SRL, registered in EUDAMED under Actor ID/SRN RO-AR-000034301 (note the unmistakable Australian connection in the name). Australian medical device start-ups can now take advantage of this additional service when addressing compliance with Article 11 Authorised representative of the Regulation (EU) 2017/745 Medical Devices Regulations (MDR).
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