I've led CE marking and FDA 510(k) submissions for Class II and III medical devices at Kounter Intuitive Technologies, supporting compliance across the product lifecycle.
I conduct gap assessments against ISO 13485 and EU MDR 2017/745, manage FMEA and clinical evaluation reporting, and compile technical documentation including CERs, BERs, risk management files, and technical files.
More recently, I supported international B2B lead generation and market mapping at Silverlight Research Group, using research, outreach, and CRM tools to identify and engage sector experts.

