Medical Device School is an online learning platform for professionals in Regulatory Affairs, Quality Assurance, and Clinical Evaluation. It offers practical, expert-led training on EU MDR, FDA submissions, literature search, SOTA, PMCF, and more — with real templates, real case studies, and results you can use at work tomorrow.

For Regulatory, Clinical, and Quality professionals working with medical devices — whether you’re in a startup, a notified body, a consultancy, or a global manufacturer. If you’re writing technical documentation, managing compliance, or improving your clinical strategy, you’re in the right place.

We go beyond basics. You’ll find modules on:

• EU MDR: Clinical Evaluation, SOTA, PMCF, SSCP, Risk-Benefit

• FDA: Clinical strategies, IDE/510(k)/PMA prep, Pre-sub pathways

• Literature Search: PRISMA-compliant searches, automation tools

• Quality Systems: ISO 13485, validation, audit readiness

• Writing Mastery: Templates, formatting, structure, reviewer-proofing

Plus, we release new modules every month, based on what’s happening now in the industry.

100% online. On-demand. No travel. No fluff.
You’ll get bite-sized video lessons, downloadable tools, and audit-ready templates. Some courses also include quizzes, feedback, and certification.

No. The training fits both beginners and experienced professionals. You’ll learn step-by-step, from regulatory logic to document structure — and get advanced tips if you’re already working in the field.

Yes. Everything is built around real-world experience with Notified Bodies and FDA reviewers. We stay on top of guidance documents (MDCG, ISO 14155, 13485, FDA guidances) so you don’t have to.

Yes. Every course includes a downloadable, named certificate you can use for internal audits, LinkedIn, or your next promotion.

Lifetime access. Once enrolled, you can come back anytime to review lessons or download materials — even after updates.

Yes — but only to subscribers. Join the newsletter to access private launch prices, bundles, and exclusive bonus content.

Subscribe to the newsletter. You’ll get:

• Early access to new modules

• Private discounts

• Free expert tips every week

• Updates on regulatory changes (MDR + FDA)

Yes. Our team is here to help. You can ask questions during select live sessions or book private coaching to review your documents or strategy.