One question per email, over about two weeks. Where to start, what performance your device must reach, which evidence route fits, who your comparators are, and how you get to market.
Written by Dr. Hatem Rabeh, MD, MSc Biomedical Engineering, who builds these files and answers what notified-body reviewers send back.
One click to leave, at the bottom of every email.
I create your clinical strategy and documents, including CEP, CER, PMCF, IP, and IB, in line with MDR and MDCG guidelines. My focus on efficiency and precision ensures swift CE approval for your medical device.
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Overcome MDR and MDCG hurdles with my proven method. I offer personalized guidance to accelerate your CE marking through expertly crafted clinical documentation and strategy. Ready to boost your medical device’s journey? Reach out to me today.