Naz’ strength lies in the ‘science’ and ‘art’ of shaping medical devices and digital health solutions to fit regulatory requirements in order to reach the hands of patients and doctors who benefit from them.

Prior to being a regulatory consultant, Naz was the Director of Quality and Regulatory at Arterys, a medical imaging start up, where she cleared the first ever cloud-based machine learning imaging 510(k) application with the FDA. She is currently involved with a number of working groups that are defining the regulatory standards for machine learning medical device products, and she also serves as one of the TMCx advisors.

Naz specializes in Digital Health, Software as a Medical Device (SAMD), Software as Service (SAS), Deep Learning, Machine Learning, AI, Medical Imaging Device, Computer Assisted Detection and Diagnostic Software, Mobile Medical apps, Telemedicine, Wearable Devices, General Wellness, and OCT Imaging regulatory submissions.

With Naz you’ll receive dedicated attention and a regulatory strategy roadmap that is customized to meet your unique needs. Her services are rooted in practical experience and in her multi-dimensional understanding of global and local regulations.

A Biomedical Engineer by education, Michelle spent half of her nearly 30 year career developing and commercializing medical devices and software before finding her true passion of intellectual property strategy. Michelle has held senior management and officer roles in medical device, medical software, and consumer product companies. Some of her past roles include VP of IP & Legal Affairs for The Sharper Image (a $750m public consumer products company) and VP of Product Development for 1747 (a clinical trials software start-up – pronounced “coolest biotech company” in 2002 by Fortune Magazine). Michelle has devoted the past 10 years to start-up companies and investors to help them increase company value via intellectual property development and strategy.

Michelle holds a bachelor’s degree in Biomedical Engineering from Rensselaer Polytechnic Institute and a master’s degree in Biomedical Engineering from Tulane University. Michelle is also registered to practice before the USPTO.

Devyani Nanduri has over 15 years of experience in leading regulatory, clinical and research initiatives in the medical devices industry. She has advanced a variety of novel technologies to the market, including a neural implant for headaches, the first retinal

prosthesis to restore sight to the blind and a novel critical care sensor/monitor. In her industry roles, she oversees the regulatory intelligence and submissions, along with clinical strategy and clinical operations for commercial and pre-commercial Medtech

products. She is also an inventor on 3 patents, has published her research in leading journals, conferences and textbooks. She also teaches a course at UCSF/Berkeley MTM Program on Clinical study strategies for the MedTech Industry that was developed for

Master’s bioengineering students. She received her Ph.D. in Biomedical Engineering and M.S. in Regulatory Affairs from University of Southern California (USC) and her B.Eng. in Electrical Engineering from University of Toronto, Canada.

Lakshman has 25 years of biopharmaceuticals and diagnostics industry experience including over 5 years at US FDA in the Office of In Vitro Diagnostics, Center for Devices and Radiological Health and as Policy Advisor to FDA Commissioner Dr. Margaret Hamburg. He has served as a member of CMS MEDCAC (Medicare Evidence Development and Coverage Advisory Committee). As a reviewer he led the first FDA-CMS Parallel Review project at the FDA. As Vice President at Avalere Health, a Washington DC based consulting firm, he has counseled a diversity of pharmaceutical, medical device and diagnostics companies and currently serves as a Regulatory Strategy advisor to Athelas and as advisor to Great Point Ventures. He has a doctorate in molecular biology from University of North Carolina at Chapel Hill (1994) with post-doctoral training at St. Jude Children’s Research Hospital, Memphis, TN.

Kristy graduated from the University of Florida with a B.S. in Economics.  She has worked in many different fields to expand her experiences in business.  Her main focus and interest has been in human resources and payroll. After taking some time to focus on her family, Kristy is excited to return to the workforce as an office manager.  This work includes scheduling, correspondence with clients, accounting and FDA regulatory submissions. Kristy enjoys working in a fast paced environment with many different elements working together.

Taranjit has been at the right place at the right time in his career of 22+ years. As a first QA hire tasked to build a world-class quality organization and QMS from scratch, he witnessed digital health revolution at Verily (Google) Life Sciences, as it spun-off from the moonshot factory GoogleX as a standalone Alphabet entity. Essentially the same feat he previously accomplished at the multi-billion $$ gene sequencing giant Illumina which spearheaded the genetic revolution.

Since 2015-16, Taranjit worked closely with FDA’s Digital Health office to develop a partnership (and facilitate a bench marking opportunity at Google) which ultimately shaped FDA Digital Health Pre-Check pilot program in 2017. Areas of his expertise include Software as a Medical Device (SaMD), digital health, machine learning/artificial intelligence, HealthIT, mobile medical apps, CDS, bioinformatics, big-data and cloud technologies, clinical trial platforms, CLIA lab/LIMS systems, and a wide-variety of medtech software applications.

The foundational years of Taranjit’s career were spent with the manufacturers of a wide array of medical devices (Class I/II/III) such as radiation therapy systems, capital equipment, surgical devices, CT scanners and IVDs. He’s worked in situations of significant FDA enforcement action. Rare for a quality assurance and regulatory compliance professional, he has hands-on experience in virtually all product lifecycle phases such as research, design engineering, software development, manufacturing operations and supply chain management.

Taranjit graduated with an MS in Electrical Engineering from Simon Fraser University (Canada), and Doctor of Regulatory Science from the University of Southern California. His dissertation included the use of tailored agile/scrum methodology for medical device software in 2008 (ahead of AAMI’s TIR 45 on the same topic in 2012). He has authored a book on Medical Device Software (2013, Scholar’s Press), and a chapter on Software in RAPS’ book on Global Medical Device Regulatory Strategy (2016). He also holds RAC from RAPS.