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  • Home
  • About Us
  • Our Team
  • Services & Expertise
    • Strategy Planning
    • Product Development and Standards
    • Regulatory Submissions
    • Re-scheduling / Re-classification Services
    • Postmarket Compliance & Surveillance
    • Regulatory and Administrative Appeals
    • Literature-Based Medicine Submissions
    • Biosimilar & Biotechnology Medicine Development
    • Due Diligence and Technical Assessment
    • Quality Management Systems
    • Authorised Representation, Sponsorship & Distribution Management
    • Reimbursement – Strategy, Advice and Submissions
    • Distribution Services
    • Diagnostics and IVDs
    • Biocompatibility
  • Blog
  • Events
  • Videos
  • Contact Us

Blog

TGA published review of safety and performance issues in Medical Device software

July 29, 2020 | | Homi Dalal

Risk Management ISO Standards – ISO 14971: 2019 and ISO TR 24971: 2019.

July 22, 2020 | | Homi Dalal

Harmonised Standards for MDR? CEN/CENELEC say “Non”

July 2, 2020 | | Arthur Brandwood

FAQs Regarding the Australian R&D Tax Incentive and Regulatory Services

July 1, 2020 | | Luis Jimenez

Addendum to TGA Deadlines: Medicine Labelling Compliance and COVID-19

June 19, 2020 | | Reena Patel

Proposed delayed commencement of certain Medical Device Regulatory Changes

June 12, 2020 | | Jean Boudaud

Software as a Medical Device – Upcoming Changes to the Australian Regulations

May 29, 2020 | | Belinda Dowsett

Keeping it Clean: Regulation of Hand Sanitisers as Cosmetics or Therapeutic Goods

May 19, 2020 | | Mirjana Rapaic

Upcoming TGA Deadlines for Medicine Labelling and Product Information Reform

May 18, 2020 | | Reena Patel

Notified Body Updates for MDD, MDRs, IVDD and IVDR

May 4, 2020 | | Luis Jimenez
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Brandwood CKC is the premier regulatory, quality systems and reimbursement consultancy in Australia serving local and international healthscience innovators for more than 20 years.

ABN: 61 128 762 505

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