Stephen Page

Mr. Page has over 30 years of experience in Regulatory Affairs and Quality Systems with a primary focus in FDA approvals and CE Marking. Over the course of his career, Mr. Page has created, updated, streamlined, and maintained quality systems for compliance with ISO standards and is an expert in regulations for FDA, EU, Canada, and Australia.

Mr. Page has submitted 510(k) Premarket Submissions, created numerous MDD-compliant Technical Files and FDA-compliant Device Master Records, and has hosted countless successful FDA inspections and Notified Body audits. He also designs and executes training programs and works collaboratively with design teams to ensure adequate adherence to regulatory standards.

Prior to joining Woven, Mr. Page worked for various medical device manufacturers including Boston Scientific and Genzyme. Mr. Page also currently runs his own QA/RA advisory firm and has ushered dozens of products through their respective regulatory processes.

Mr. Page received his BA from New England College.