
AI Governance in Drug and Device Development Professional Certificate
About 14 hours
Written for regulatory, quality, data science, and digital health professionals who must deploy or evaluate AI in regulated life-science work.
$395 per person. Online and self-paced.

Who it is for
Regulatory, quality, data science, and digital health professionals who must deploy or evaluate AI in regulated life-science work.
What you will learn
- Define the context of use and risk level for an AI model
- Apply FDA's credibility assessment steps to a drug development use case
- Outline a PCCP for an AI-enabled device
- Determine EU AI Act obligations for a product or internal tool
- Draft an AI governance policy for a GxP organization
How it works
Online and self-paced
The lessons are online, with an audio version of each, so you can study at your own pace.
Earn a certificate
Finish every lesson to receive a certificate with a unique ID that anyone can verify.
Enroll online
Pay securely by card, Apple Pay or Google Pay. Your account is ready as soon as the payment goes through.
More in Data, AI & Real-World Evidence
See the trackQuestions about this program
How long does AI Governance in Drug and Device Development Professional Certificate take?
About 14 hours of study. It is online and self-paced, so you can spread it over the weeks that suit you.
Who is this program for?
Regulatory, quality, data science, and digital health professionals who must deploy or evaluate AI in regulated life-science work.
Do I get a certificate?
Yes. When you finish every lesson you receive a digital certificate of completion with a unique ID that anyone can check at regulatedscience.org/verify/. You can add it to your LinkedIn profile.
Is there an audio version?
Yes. Every lesson has an audio version, so you can listen on the go.
How much does it cost?
$395 per person. Email support@regulatedscience.org for team pricing.
How do I enroll?
Select "Enroll" on this page and pay securely by card, Apple Pay or Google Pay. Your account is ready as soon as the payment goes through.
Can my team take it together?
Yes. We offer group enrollment for companies, CROs and consultancies. Email support@regulatedscience.org with the programs and the size of your team.
Not ready to enroll?
Leave your email and we will send you the syllabus and news about this program. You can ask us to remove it at any time.







