The specialist CER partner medical device manufacturers trust to get it right — first time. Getting a Clinical Evaluation Report (CER) wrong is potentially a costly mistake for commercial timelines. Since it has become the law of the land (specifically in the EU), Notified Bodies review CER submissions fairly strictly under EU MDR 2017/745 — and the consequences of non-compliance extend far beyond a simple request for additional information. Delayed CE marking, stalled product launches, and...

Navigating the transition from MDD to EU MDR 2017/745 has turned Clinical Evaluation Reports (CERs) into perhaps the single most important gateway to CE certification in the EU. A CER is no longer a simple summary that gets stuck in a drawer after writing; it is a rigorous, evidence-based demonstration of safety and performance that must withstand the scrutiny of Notified Bodies. Spiral Medical Development (SMD)  specializes in clearing these regulatory hurdles. We provide end-to-end clinical...

Old martial arts movies, including those of the sci-fi variety which have wise green aliens always have a scene where the student sits at...