Home » Expert Consults » Expert Consult with Rory A. Carrillo, Cosm: AI/ML FDA Regulation and Clearance

Expert Consult with Rory A. Carrillo, Cosm: AI/ML FDA Regulation and Clearance

November 4, 2021

Are you developing a novel medical device or using AI/ML, and do you want to know how the FDA will regulate your product and what you need to get FDA clearance or approval?

Apply to talk with our expert on FDA clearance and approval, Rory A. Carrillo of Cosm, for a 45-minute slot on the morning of Thursday, November 4, 2021.

Cosm specializes in developing and implementing regulatory strategies for novel medical devices, including those leveraging AI/ML technologies. From all things quality and regulatory for medical devices, combo products, and IVDs, Cosm can help you understand how the regulatory authorities around the globe will regulate your product and what data might be expected for your submission.

About Rory A. Carrillo 

Rory A. Carrillo is a Medical Device professional with 14 years of experience gained working in the U.S., Canada, EU, and South America.

Rory has held leadership roles in Engineering, Quality, and Regulatory. Rory started as a Systems Engineer and technical lead developing complex imaging and cardiac ablation products while at Boston Scientific and a startup called Tornado Medical Systems. Rory realized his passion to mentor and guide startups while at Tornado Medical as the company of 30 people had no medical device development experience. While leading the development of a novel, first-of-a-kind product, he also mentored the team to understand the quality and regulatory requirements.  

Since 2012, Rory has consulted and led several companies in developing and implementing their quality and regulatory strategies and systems to comply to appropriate standards and regulations and successfully gain clearance to the U.S, Europe, Canada and other international markets. The companies and products that Rory has led and supported range from complex imaging systems, to wearables, mobile apps, cloud-based AI/deep-learning SaMD, and digital health products to name a few. Recently, Rory has focused on supporting early-stage startups to gain market clearance for their cloud-based deep-learning SaMD products. Additionally, Rory has extensive experience in getting electro-mechanical Class II and Class III devices to market clearance and commercialization.

Rory has earned a B.S and M.S from California Polytechnic State University San Luis Obispo, specializing in Electrical Engineering and Biomedical Engineering. Additionally, Rory has Six Sigma Yellow Belt Certification from Boston Scientific.

Key competencies include: FDA 21 CFR 820, EU MDD & MDR, ISO 13485:2016, IEC 60601-1 3rd ed., IEC 62304, IEC 62366, ISO 14971, HIPAA, GDPR, HITECH, Cybersecurity, Human Factors, Artificial Intelligence and Deep Learning, Agile Software Development, Clinical Study Protocol Development and Testing, FDA Premarket Notifications, CE mark 

Our Expert Consults are hosted by leading experts who have generously offered their services pro bono to our entrepreneurs.

If you choose a timeslot, we will require a $100 credit card deposit. The deposit will be refunded the day after you attend. No-shows will not receive a refund. Please be punctual; arrivals late by more than 15 minutes will be considered no-shows.

If you find that you are unable to attend, you may request a refund up to 5 days in advance. (This will give us time to offer the slot to the first person on the waitlist.) We regret that we cannot honor requests made at a later time.