Experience technical/scientific writer in various categories of the medical devices industry such as cardiology, ophthalmology, orthopedic, dental, gastroenterology and others. My experience includes Regulatory strategies and submissions for FDA and CE , Clinical and pre-clinical study protocols, investigator's brochures, clinical study reports, risk management plans Risk/benefit analysis according to ISO 14971- 2012 . Marketing, biocompatibility consultant , analysis strategies, Usability engineering file according to IEC 62366 (Medical Devices 鈥� usability) and FDA Guidance.
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