An experienced clinical research and medical device Technical file writer who has certified on MEDDEV 2.7/1 Rev#4 documentation, EU MDR, ISO-10993, and FDA compliance. Provided strategic support in regulatory affairs, post-market product surveillance, and quality assurance in CE marking of EU Class I, IIa, IIb or III medical devices by writing Clinical Evaluation Reports (CERs) providing clinical evidence of the device's state of the art for medical treatment and its safety and performance and response to notified body feedback. I would be eager to consult on new projects moving forward.