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Lana Widman has extensive experience working with medical device manufacturing firms from startup to full scale manufacturing. Lana has held key positions in Quality Assurance and Regulatory Affairs focused on helping organizations take the fear out of quality and implementing Smarter Quality Management Systems that add value to the business. Lana has strong knowledge of FDA, European, and California Health & Safety Code regulations. She is certified as an ISO 13485 Lead Auditor and ISO 17025 Auditor.