Nancy Sauer

Background

About Nancy Sauer

I am a seasoned medical device regulatory affairs professional, equally at home with developing and executing regulatory strategies that bring new products to market and sustain them through their life cycle. I use a highly collaborative approach to find the pathways that are feasible, aligned with business strategy, and in compliance with regulations. I love this work because I know I make a difference in the world every day. Key skills and experience Effective 510(k) submissions for many device types CE marking under MDD and MDR UKCA certification IDE submissions Device reclassification Understanding of global regulatory landscape Life cycle support of products (change review, letters to file, submissions, etc.) I have experience with many medical device types: Active devices: electrosurgical hardware and instruments, vessel sealing systems, ultrasonic systems, dialysis equipment, blood handling systems, visualization systems, software-controlled systems Implanted devices: implanted shunts and catheters, meshes, clips, and sutures Non-active devices: trocars, endoscope accessories, and various hand instruments for minimally invasive surgery In vitro diagnostic devices I have worked with both small and large companies, always understanding the need to align regulatory strategies with business strategies. I also know that my success requires intense collaboration with other stakeholders - business strategy, R&D, quality, clinical, marketing, and operations. I also treat our regulators as important partners and stakeholders. They are in many ways one of our most important customers.