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.