Blog
26 January 2026
Presentation of LEXQARA CER tips and tricks to avoid common key pitfalls
26 January 2026
The proposed 2025 MDR amendments aim to make clinical evaluation more efficient by expanding acceptable...
26 January 2026
This post explains how to strengthen and maintain an MDR CER through data stratification, GSPR-aligned...
26 January 2026
Article 61(10) allows some non–Class III/implantable MDR devices to justify compliance using only technical/preclinical...
26 January 2026
This post clarifies the difference between equivalent vs similar devices in an MDR CER—equivalence supports...
26 January 2026
This post explains how to strengthen an MDR CER by structuring device claims, running robust SOTA/DUE...
26 January 2026
The article explains how to build a strong State of the Art (SOTA) section in an MDR CER by defining...
26 January 2026
The article explains how to strengthen the foundations of an MDR CER by defining scope early, ensuring...
13 June 2025
Structured Dialogue is a valuable, early-interaction tool under MDR that helps manufacturers clarify...
20 March 2025
Ensure MDR compliance with PMCF! Learn key steps, best practices & download ready-to-use templates....
18 March 2025
WET under MDR Article 61 vs. MDCG 2020-6: Understand key differences, compliance benefits, and evidence...