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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

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TGA REGISTRATION

Agent services for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG)

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SAFETY CERTIFICATION

Certification of imported electrical medical devices to Australian safety standards AS/NZS 3200.1, AS/NZS IEC 60601.1

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