ISO, MDR & FDA: Medical Device Certification Explained
25-minute breakdown for health tech teams navigating EU and US regulations.
Architecture of the regulatory landscape: ISO 13485 certification, MDR, and FDA, without the legal jargon. Watch on demand after signing up.A practical guide through the three certification systems that determine whether your medical device ships. Understand what ISO 13485 certification, EU MDR, and FDA approval actually require from your team, before they derail your roadmap.
Why Medical Device Compliance Confuses Most Health Tech Teams
Most teams start building a health app and hit the regulatory wall four months in. ISO 13485, MDR, CE mark, notified bodies, 510k, each acronym leads to ten more. You're not sure which standards apply to your device class. You don't know when to bring in a QMS consultant. And nobody's explained how the EU and US systems actually connect.
The standards tell you what to implement. They don't tell you how ISO 13485 certification, EU's MDR, and the US FDA fit together, or which one matters for your specific device, timeline, and market.
This webinar gives you a clear mental model of medical device compliance so your team can make the right calls before they become expensive ones.
What's Inside
Why Medical Devices Are Regulated
Why governments mandate certification for medical devices and what it means that medical device compliance is compulsory, not voluntary. The framework for thinking about safety vs. novelty in health tech.
ISO Standards You Actually Need to Know
A practical overview of ISO 13485 (quality management), ISO 14971 (risk management), ISO 62304 (software lifecycle), ISO 62366 (usability), and IEC 6601x (electromechanical devices). Which require ISO 13485 certification, which require implementation only.
MDR: How EU Medical Device Regulation Works
How the European Parliament regulation flows through national offices to notified bodies and what that means for your CE mark, timeline, and cost. Device classes I, IIa, IIb, III and how they affect your documentation requirements.
The MDR Certification Process, Step by Step
From device class determination and intended use through QMS implementation, technical documentation, laboratory testing, and the two-stage MDR audit. Where health tech teams typically get stuck.
FDA: How the US Does It Differently
Why FDA operates without notified bodies, how their guidances differ from EU guidances, and why political dynamics matter more than you'd expect. Key structural differences that affect how you prepare your submission.
FDA Procedures: Q-Sub, 510k, De Novo and PMA
A practical breakdown of all four FDA pathways, from pre-submission meetings through predicate-based 510k clearance, De Novo for novel devices, and PMA for class III. Including predicate creep and why most companies fight to stay in 510k.
What Prepared Teams Know Before They Start
The difference between teams that ship on time and teams stuck in compliance debt is usually one thing: when they learned this.
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Who Needs This Recording
CTOs and Engineering Leaders
Understand the regulatory constraints that shape your architecture decisions before you're four months into a build you'll need to rework.
Product Teams and Founders
Get the realistic scope, timeline, and cost of medical device compliance before committing to a regulated product roadmap.
Health and Wellness Innovators
Know enough about ISO 13485, MDR, and FDA to have credible conversations with clients navigating certification.
Expert Quote
