VP of Operations & Principal Consultant Nichole Leahy-Glass

With 14 years of experience in the medical device industry, Nichole Leahy-Glass is an accomplished medical device expert and a driving force behind MedLaunch. As Co-Founder and Chief Operations Officer, she brings a wealth of knowledge and a track record of success in regulatory compliance and operational excellence.

Nichole’s journey in the medical device sector began at Purdue University, earning her B.S. in Biomedical Engineering. Her expertise is further backed by a range of professional certifications, including being an ASQ Certified Quality Auditor and holding a Lean Manufacturing Certificate from the University of Michigan, along with ASQ Process Validation Training. These qualifications underscore her deep understanding of quality assurance and efficient manufacturing practices.

Before co-founding MedLaunch, Nichole’s impressive career included notable senior-level and executive roles at G&H Orthodontics, where she started as the Director of Quality Assurance and Regulatory Affairs and was promoted to Vice President of Operations and RA/QA.  As Vice President of Operations, she oversaw two manufacturing plants and over 200 employees during her tenure. Her achievements in streamlining processes, enhancing product quality, and navigating complex regulatory landscapes have set high industry standards.

At MedLaunch, Nichole leverages her extensive experience to guide medical device startups and established firms through the intricacies of product development and market compliance. Her commitment to operational excellence and her strategic approach to regulatory challenges make her an invaluable asset to the MedLaunch team and its clients.