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KD&A - Regulatory Consultants for Medical and IVD devices

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logo main
  • About Us
    • About Us
    • What our Clients Say
    • Frequently Asked Questions
  • Our Services
    • Medical Device Regulatory Strategy
    • ISO 13485/ MDSAP QMS Maintenance, Internal Audit and Support
    • Technical File Documentation
    • Global Medical Device Registrations including ARTG Inclusions/TGA Registrations
    • Post Market Surveillance
    • TGA Conformity Assessment / CE Marking
    • Promotional Materials Review
    • Australian TGA Sponsor Services
    • Medical Device and IVD Classification Assessment
    • Software as a Medical Device (SaMD)
  • Our Clients
    • Australian Sponsors & Distributors
    • Medical Device Manufacturers
    • International Medical Device Manufacturers
    • Our Clients
  • News
  • Useful Links

Regulators Tag

04
Apr
Regulatory ChangesTGA

The Next Phase of the Global Harmonisation Task Force (GHTF) Evolution

The Next Phase of the Global Harmonisation Task Force (GHTF) Evolution…

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Latest Articles
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KD&A Can Help You From the Start – Medical Devices Steps to Market
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New Regulatory Changes for Medical Devices Containing Medicinal Substances, Animal, Microbial, or Recombinant Materials
August 1, 2024
Navigating the Updates to TGA Guidance on Excluded Software and Essential Principle 13B
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+ 61 411 101 392
kdent@kdas.com.au

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KD&A provides expert regulatory consulting service to medical device and IVD companies selling on Australian and International markets.

    Contact us:
    kdent@kdas.com.au
    +61 411 101 392
    Our address:
    Level 3, Suite 301,
    27 Belgrave Street,
    Manly NSW, Australia
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