Hardware Podcasts

Managing Clinical Data Activities

Global Medical Device Podcast · 7 Jul 2021 · 24m · Episode 218

What this episode covers

Pall Johannesson, CEO and co-founder of Smart Trial, explains how his digital platform helps medical device companies manage clinical data activities, addressing the industry's historical reliance on outdated paper and Excel-based systems. He discusses the impact of EU MDR and the pandemic on clinical trial strategies, noting a shift toward decentralized or hybrid trials and the importance of collecting clinical evidence early to avoid regulatory delays. Johannesson highlights common mistakes, such as collecting too much data without statistical rigor, and emphasizes best practices like involving statisticians early and planning for post-market surveillance from the start.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Smart Trial, Green Light Guru
Products
Halo
Also
EU MDR, FDA

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