Articles & Blogs, Newsletters, Collaborated Pieces - written to make complex clinical and regulatory topics genuinely useful.
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The CER sits at the heart of a symbiotic, cross-functional system — drawing inputs from Risk, Quality, Regulatory, Post-Market Surveillance and clinical experts that together shape its scientific validity.
Read on LinkedInThe Summary of Safety & Clinical Performance is not a promotional document. It's part of the Clinical Evidence Trilogy under EU MDR — alongside the CER and PMS. Here's what it genuinely demands.
Read on LinkedInAI can now produce a "perfectly written" CER draft — which I'd argue is simultaneously a recipe for a failed submission. A look at the growing paradox in clinical evaluation.
Read on LinkedInWhat does "sufficient" clinical evidence really mean? A deep dive that grew out of a daily-writing series — where every topic demanded its own investigation.
Read on LinkedInI ran a poll asking what makes the Clinical Evaluation Report feel difficult. The top answer: "too scientific / too clinical." I agree — to a point. Here's the rest of the story.
Read on LinkedInReflecting on a pivotal client challenge that captured the complex realities of Clinical Evaluation under EU MDR — where regulatory expectations meet business urgency.
Read on LinkedInThere is a web of regulatory relationships — claims, evidence, risk, benefit, SOTA — that needs clear definition. The opening chapter decodes one critical, frequently misaligned partnership in regulatory strategy: the relationship between Intended Use and Clinical Claims.
Read on LinkedInPart 1 established the first crucial relationship — between Intended Use (the boundary for a device's use) and Claims (staying within it). Part 2 builds directly on that foundation: The Relationship Between Intended Use and Device Classification.
Read on LinkedInWith Intended Use, Claims and Classification established, Part 3 turns to the Relationship Between Intended Use and Clinical Benefits — because as humans we always evaluate what's in it for us: whether something improves our lives or helps us achieve a better outcome.
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