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PMCF under MDR: from regulatory obligation to competitive advantage
In many medical device companies, Post-Market Clinical Follow-up (PMCF) is still seen as a burden — a bureaucratic requirement introduced by the EU MDR (EU 2017/745) that adds cost and pressure to already overloaded regulatory teams. That view is increasingly short-sighted.Companies that treat PMCF purely as compliance are missing a significant strategic opportunity. The MDR…
Real-World Evidence and MDR: why post-market data often matters more than trials
There is a paradox in medical device research that is rarely discussed openly. The most controlled, expensive and rigorously monitored method of generating clinical evidence (the interventional trial) often produces evidence that becomes less useful once the device enters real clinical practice. Clinical trials typically ask: Does the device work under optimal conditions, with selected…
Innovative medical device in 2026: how to build an evidence strategy that holds…without drowning in rework
There’s a sentence we hear often from founders, Clinical Affairs and Regulatory teams: “We have a strong device, but we’re afraid of losing time.” Not time spent working.Time lost to rework, the kind that appears halfway through a study, when you realize it started… but wasn’t solid enough. Studies don’t fail because there’s a lack…
Risk-based means protecting what matters most
In clinical research, risk-based approaches are everywhere: they appear in protocols, monitoring plans, and quality systems. But there is a growing misunderstanding. Many organizations treat risk-based as a justification to reduce activities: fewer checks, lighter processes, less on-site monitoring. The goal is often simple: cut time and cost. Technically and regulatorily, this interpretation is wrong.…
Digital twins in Clinical trials: a new way of designing studies
In the past year, Digital twin has become one of the most overused terms in healthcare innovation. It appears in conference slides, CRO strategy decks, and investor presentations, often described as a virtual copy of a patient, ready to be tested like an avatar in a simulation. But the reality is less cinematic and far…
MDR – Corsa contro il tempo per il tuo marchio CE
L'estensione è qui, ma non è una rete di sicurezza. Scopri come muoverti velocemente, rimanere conforme e proteggere la tua quota di mercato. Con il Regolamento (UE) 2023/607, la Commissione Europea ha introdotto una proroga fondamentale delle scadenze MDR per i dispositivi legacy certificati ai sensi del precedente MDD (Direttiva 93/42/CEE). È un'opportunità preziosa—ma non una scusa per ritardare.…