7 min read
Monthly FDA Guidance and Regulatory News Review - April 2026
This April 2026 regulatory update highlights new policies on biomarker validation, expanded access to investigational...
As MD and IVD regulations evolve in Europe, you need the right partner to guide your planning and decision-making to successfully certify your device. Veristat’s team of highly dedicated and experienced regulatory professionals provides impactful strategic regulatory and operational support on both a full-service or functional service basis, including technical documentation development, CER/PER, statistical support, and data management for your MD clinical investigations and IVD performance studies.
We ensure the fulfillment of every aspect of your regulatory requirements, from strategy-setting to submissions and approvals and post-approval maintenance.
Veristat team members Darren Taylor Senior Business Development Director and Andrea Larrañaga Associate Manager, Regulatory Affairs, will be at the venue— ready to listen to your needs and share Veristat’s expertise.
https://www.veristat.com/regulatory-medical-device-ivd
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Website: Medtech Forum EU
7 min read
May 20, 2026 Veristat Blog
This April 2026 regulatory update highlights new policies on biomarker validation, expanded access to investigational...
3 min read
Apr 27, 2026 Veristat Blog
When an oncology drug is tested, the signal is often brutally clear. A tumor either shrinks on a scan or it does not. A...