Digital Health Product & Regulation Certification

The Digital Health Product & Regulation Certification is a free intermediate-level, 20-minute skill test from Science of Apps. It tests digital health product and regulation — software as a medical device (SaMD) and the IMDRF risk framework, FDA pathways such as 510(k), De Novo and PMA, AI-enabled devices and predetermined change control plans, the EU MDR, clinical evidence and the NICE evidence standards framework, IEC 62304 software lifecycle and ISO 14971 risk management, HIPAA privacy and security, interoperability with HL7 FHIR, cybersecurity, usability and human factors, reimbursement and adoption, and remote monitoring and telehealth — written for 2026 and 2027. Score 70% or more on its 20 questions to earn a verifiable Digital Health Product & Regulation certificate (SOA-DHPR). Every question is based on published standards and research — including Premarket submissions: selecting and preparing the correct submission (US Food and Drug Administration), Artificial Intelligence-Enabled Medical Devices (US Food and Drug Administration), Evidence standards framework for digital health technologies (NICE) — and each answer is explained with its source.

Science of Apps offers a free Digital Health Product & Regulation Certification, written for 2026 and 2027. It tests digital health and SaMD, regulatory pathways, evidence, quality and safety and data, interoperability and adoption with 20 original scenario questions in all, each naming its published source; you get an instant score and a verifiable certificate with a credential ID you can add to LinkedIn.

Read the four skill areas on this page, then take the 20-minute test online — no fee, course or sign-up. You see every answer explained when you finish. Score 70% or more and you get a Digital Health Product & Regulation certificate straight away, on screen, as a PDF and by email, with a credential ID anyone can verify.

Yes. The questions are original scenarios written by Science of Apps, and each one is based on a public source you can read: Premarket submissions: selecting and preparing the correct submission (US Food and Drug Administration); Artificial Intelligence-Enabled Medical Devices (US Food and Drug Administration); Evidence standards framework for digital health technologies (NICE); Software as a Medical Device (SaMD): key definitions and risk categorisation (International Medical Device Regulators Forum); Telehealth.HHS.gov best practice guides (U.S. Department of Health and Human Services); Regulation (EU) 2017/745 on medical devices (MDR) (European Union). The source is shown under each question and linked in the answer review. Science of Apps doesn't copy questions from other tests.

Four skill areas with five questions each, drawn from a bank of 10 per area so a retake brings new questions: Digital Health and SaMD (Defining SaMD, Risk classification and Intended use); Regulatory Pathways (FDA pathways, EU MDR and AI-enabled devices); Evidence, Quality and Safety (Clinical evidence, Quality and software lifecycle and Risk and human factors); Data, Interoperability and Adoption (Privacy and security, Interoperability and Reimbursement and adoption). Every question is an original scenario written to the 2026–2027 standard, with the published source named under it.

Digital health product manager, Regulatory affairs professional, Health tech founder or engineer, Clinical informatics specialist and Healthcare innovation consultant. It suits students at leading universities, career switchers and experienced professionals who want quick, verifiable proof of Digital Health Product & Regulation knowledge in 2026 and 2027.

Pre-med, public-health and biotech students (Johns Hopkins, Harvard, Karolinska, Oxford, Duke) increasingly enter industry and policy roles. Passing earns a founder-signed Science of Apps certificate with a credential ID and QR code that recruiters can verify.

When its intended purpose is to diagnose, treat, cure, mitigate or prevent disease, or drive clinical management. General wellness apps and many administrative tools are not regulated as devices.

An FDA mechanism that lets manufacturers of AI-enabled devices describe planned model updates and how they will be validated, so specified changes can be made without a new submission each time.

Yes. The test is online, in English and free everywhere — people take it from India, the US, the UK, Europe, Africa, Latin America and Asia-Pacific. Your certificate is dated with your own local date and can be verified from anywhere at scienceofapps.com/certification/verify/.

20 questions — 5 from each of 4 skill areas — with a 20-minute limit. You need 70% (14 of 20) to pass and 90% for distinction.

We rate it Intermediate: assumes hands-on experience in the role. It has 20 scenario questions — 5 from each of 4 skill areas — and a 20-minute limit. You need 70% (14 of 20) to pass and 90% for distinction.

Nothing. There is no fee to take a test, to receive the certificate, to have it emailed or to verify it, and no sign-up.

On our server, not in your browser. The answers never reach the page until you submit, so a certificate can only be earned by passing. Each certificate gets a unique credential ID stored by Science of Apps.

You see your score for each area and every question with the correct answer and why, with the published source behind it. You can retake after 30 minutes, and the retake draws questions you haven't seen yet.

No. Every certificate is dated, so it always shows when you passed. Retake a test any time for a newer date or a higher score.

Yes. After you pass, Add to LinkedIn opens the Licenses & certifications form with the certificate name, Science of Apps as the issuer, the issue date, your credential ID and the verification link filled in. You can also download it as a PDF or PNG, and it's emailed to you as a PDF.

Every certificate has a credential ID and a QR code. Scanning it, or entering the ID at scienceofapps.com/certification/verify/, shows the holder's name, the certification, the score and the issue date from our records.

No. They are Science of Apps' own assessments of applied skill. They aren't issued by a university or standards body, and they work best alongside a portfolio that shows the skills in real work.