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KD&A - Regulatory Consultants for Medical and IVD devices

kdent@kdas.com.au
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    • 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
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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

International Medical Device Regulations Tag

27
Aug
EUFDARegulatory ChangesTGA

International Medical Device Regulators Forum (IMDRF) Progresses

At a meeting held in Singapore the International Medical Device Regulators Forum (IMDRF) (initiated to carry out a similar role to the now disbanded Global Harmonisation Task Force

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Latest Articles
December 6, 2024
KD&A Can Help You From the Start – Medical Devices Steps to Market
September 1, 2024
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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Australia Australian Medical Device Regulatory Framework European Union Manufacturer's Evidence Medical Device Medical Device Regulations Medicinal Substances Regulatory Changes Regulatory Compliance Regulatory Requirements Regulatory Strategy TGA

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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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    © 2024 KD&A Pty Ltd
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