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Blog & Articles related to Medtech

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Blog & Article

FDA clarifies use of Clinical Data in Premarket Notification Submissions

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Blog & Article

FDA new guidance for predicate devices

21st March 2024

Europe Regulation

Blog & Article

European Commission proposes conditional extension of IVDR requirements

11th March 2024

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Blog & Article

FDA takes steps to harmonize medical device QMS requirements

7th March 2024

Blog & Article

Hong Kong paves the way for mandatory regulatory framework for medical devices

13th February 2024

Blog & Article

Regulation of Companion Diagnostics in Australia

17th January 2024

Blog & Article

Developments in Biocompatibility Standards

3rd January 2024

Blog & Article

Preparing for device tracking: Next steps with Australia’s UDI

16th November 2023

Blog & Article

Understand Implications of Latest Amendment to MDR and IVDR published in March 2023

23rd August 2023

FDA Blog

Blog & Article

FDA starts 2023 with a flurry of guidance documents

24th July 2023

Blog & Article

ARCS Takeaways: IVDR in an Australian Context

17th July 2023

Blog & Article

TGA updates its reclassification timelines

11th July 2023

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Strategic and Scientific Consultancy
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Local Affiliate Services
Business and Portfolio Mergers & Acquisitions

Strategic and Scientific Consultancy
Integrated Product Development
Innovations to Market
Post-launch Outsourcing
Local Affiliate Services
Business and Portfolio Mergers & Acquisitions

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