quality and
regulatory.

Solutions from advice to full execution — so you can focus your time where it matters most. Establishing and managing in-house quality or regulatory affairs is a costly, time-consuming part of med-tech commercialisation. Consultants often help with fragments of the process — not the full journey.

Actis Medical is different. We don’t just advise — we’ve done it ourselves. Our services are backed by real experience, with ISO 13485, MDSAP, and MDR certifications already achieved and maintained in-house.

Quality Management Systems

  • Assist with setup, integration, and ongoing maintenance of your eQMS — using our purpose-built, fully integrated system, developed in-house and globally approved.
  • Use our approved PMMD quality system or work with us to design, implement, and maintain one tailored to your business — covering the full lifecycle from planning through to manufacture and release.
  • Full risk management development — including product, process, and usability risk files
  • Compliant with ISO 13485, QSR (FDA, TGA), MDR, and MDSAP
  • ARTG and Prescribed List applications and ongoing maintenance

Regulatory Affairs

We manage the entire regulatory process — from building technical files and design dossiers to responding to regulatory authority and Notified Body queries.

  • FDA 510(k) submissions, exemptions, and device listings
  • CE Marking under MDR and legacy MDD frameworks
  • TGA Conformity Assessment (Class I, IIa, IIb, III), including ARTG registration
  • Regulatory pathways for patient-matched devices in Australia, Europe, and the US