Global Medical Device Compliance
Medical device registration across the EU (MDR), US (FDA 510(k)), India (CDSCO), and Canada (Health Canada).
4 full video courses — plus all 4 companion books included free.
One-time purchase · Lifetime access · No subscription
What's included
EU MDR Certification Course (MDR 2017/745)
EU MDR 2017/745 certification step by step: Annex VIII classification, notified bodies, GSPRs, technical file, clinical evaluation, QMS and post-market.
+ companion book included free
FDA 510(k) Course: Medical Device Registration
FDA medical device registration for hardware startups: classification, 510(k) vs De Novo, predicates, design controls under QMSR, testing and clearance.
+ companion book included free
CDSCO Medical Device Registration Course (India)
Get a medical device licence in India: CDSCO classification (Class A–D), the Indian authorised agent, import licence dossiers and post-market duties.
+ companion book included free
Health Canada Medical Device Licence Course (MDL)
Get a Health Canada medical device licence: Class I–IV rules, MDEL vs MDL, MDSAP audits, Class II–IV applications, clinical evidence and post-market duties.
+ companion book included free