29 Sep

CBA launches its permanent consulting service for MedTech companies requiring regulatory and quality management systems support.

Our Principal Consultant, Val Theisz, MSc RAC (EU, US) is now fully dedicated to providing medical device consulting services to MedTech companies requiring regulatory and quality management systems support.

Since its establishment in 2010, Certification Body Australia has been providing services to medical device importers such as certification of imported electrical medical devices to Australian safety standards, TGA registration and inclusion of medical devices into the ARTG, and compliance training and regulatory workshops. In recent years we have seen an increase in demand for dedicated regulatory and quality management system consultancy services for MedTech start-ups. Our Principal Consultant Val Theisz, MSc RAC (EU, US) is now fully dedicated to providing comprehensive, tailored consultancy services for medical device companies covering:

  • Medical devices of all risk classes, including high-risk active implantables and SaMD using artificial intelligence (AI) models
  • Key target markets – EU, US, Australia, Canada, Japan
  • Setting up quality management systems compliant with ISO 13485, EU MDR and FDA 21 CFR 820 (QSR)
  • Submission-ready tech files for EU MDR, FDA 510(k) and PMA
  • Premarket regulatory strategy and planning
  • Post-market compliance
  • Advertising for medical devices, compliance with advertising regulations and codes
  • Unique Device Identification (UDI)

No matter how big or small, your medical device project is important to us. Contact Val at val.theisz@marketaccessaus.com.au for more information

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