Navigating Today's FDA Landscape: SaMD, SiMD,
Interoperable IVDs, and Regulatory Strategies

Connie Qiu is a regulatory affairs professional with more than 10 years of experience providing regulatory and quality system support to the medical device industry. She has prepared and managed multiple regulatory projects which support FDA pre-submission meeting packages as well as 510(k), De Novo, PMA and PMA supplement submissions. 

Ms. Qiu is a subject matter expert for software-based devices and interoperable medical devices containing a software component, including SaMDs leveraging Machine Learning and Artificial Intelligence. She is knowledgeable in development of sound regulatory strategies for all classes of medical devices, including preparation of testing requirements, software risk assessment, electrical safety and human factors testing. Ms. Qiu also supports clients in preparing software documentation for their Design History Files.  

Connie has developed regulatory strategies for innovative technologies from monitoring devices to diagnostics, as well as wellness products.  

Brendan O’Leary advises technology developers, healthcare organizations, trade and professional associations, and others on digital health and medical technology development, evaluation, and regulation.

Brendan worked at the FDA for 14 years in a variety of roles focused on medical devices, diagnostics, and digital health. Most recently, he served as the founding Deputy Director of the FDA's Digital Health Center of Excellence. Throughout his career at the FDA, Brendan contributed to hundreds of precedent-setting decisions and co-authored dozens of policies that continue to provide the foundation for the FDA's digital health efforts. He frequently represented the FDA on digital health and other topics at conferences and professional society meetings, in press interviews, and in interactions with Congress. Brendan also made significant contributions to the federal government's response to SARS-CoV-2.

Early in his career, Brendan designed and developed tools that were used by NASA astronauts to repair the Hubble Space Telescope. He has a B.S. in Mechanical Engineering from the University of Maryland, College Park.

Brendan lives in Maryland with his wife, Jessica, and their dog, Bear.

Cortez McBerry, PhD, is a regulatory expert on ProPharma’s Regulatory Sciences team (formerly NDA Partners), where he assists clients in all facets of medical device development and regulation in the US. Prior to joining ProPharma, Cortez was a Partner with NDA Partners, a ProPharma company, and served as Regulatory Consulting Director with the company from 2021. He was formerly a Lead Reviewer in the FDA Division of Immunology and Hematology Devices in the Office of In Vitro Diagnostics (CDRH), where he was responsible for reviewing De Novo requests, PMAs and 510(k) applications for in vitro diagnostic products, reviewing companion diagnostics in IND/BLA applications and in vitro diagnostics in drug/therapeutic labels, conducting meetings with industry, and developing regulatory strategies and policies. He is experienced in regulatory strategy, regulatory affairs, labeling, and managing US, EU, and Notified Body regulatory submissions for medical devices and in vitro and companion diagnostics.

In addition to his FDA experience, Dr. McBerry also served as Senior Regulatory Affairs Manager at Becton, Dickinson and Company (BD), Integrated Diagnostic Solutions (IDS), in Baltimore, Maryland. While at BD, Dr. McBerry was responsible for the management of the regulatory lifecycle of molecular instruments and assays, which included development of regulatory strategy, negotiating with various regulatory agencies, authoring regulatory submissions, and promotional material review. In his early career, he was a post-doctoral fellow with the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH).