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Read more about the article Combo Products, Complex Rules: Regulatory Strategies for Combination Products

Combo Products, Complex Rules: Regulatory Strategies for Combination Products

  • Post author:Alex Chappell
  • Post published:September 5, 2025
  • Post category:Insider/Regulatory

Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in Life Sciences and Regulatory Affairs. This time, I’m joined by Plamena Entcheva-Dimitrov, PhD,…

Continue ReadingCombo Products, Complex Rules: Regulatory Strategies for Combination Products
Read more about the article MHRA consider dramatic changes to the regulation of medical devices and in vitro diagnostics

MHRA consider dramatic changes to the regulation of medical devices and in vitro diagnostics

  • Post author:Sean Carpenter
  • Post published:July 22, 2025
  • Post category:Blog/Regulatory - Blog

The MHRA recently closed their consultation on routes to market for medical devices and in vitro diagnostic devices. The consultation, which closed on 5 January 2025, asked for input on…

Continue ReadingMHRA consider dramatic changes to the regulation of medical devices and in vitro diagnostics
Read more about the article eCTD 4.0 & Medical Devices: What’s Happening in 2025?

eCTD 4.0 & Medical Devices: What’s Happening in 2025?

  • Post author:Alex Chappell
  • Post published:February 14, 2025
  • Post category:Insider

Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs. For the first episode, we're joined by Diarmuid Waide,…

Continue ReadingeCTD 4.0 & Medical Devices: What’s Happening in 2025?
Read more about the article Compliance without Compromise: Med Device RIM & QMS

Compliance without Compromise: Med Device RIM & QMS

  • Post author:Alp Tetikel
  • Post published:January 2, 2025
  • Post category:Insider/Quality/Regulatory

Continue ReadingCompliance without Compromise: Med Device RIM & QMS

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