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 โ plus all 4 companion books included free.
One-time purchase ยท Lifetime access ยท No subscription
What's included
EU Medical Device Regulation (MDR 2017/745) โ Complete Certification Guide
The complete EU Medical Device Regulation (MDR 2017/745) certification course โ from first-principles scoping to a defensible technical file, a live quality system, and full post-market compliance.
+ companion book included free
FDA Medical Device Registration & 510(k) for Hardware Startups
The complete FDA medical device registration course for hardware startups โ from first-principles scoping to a cleared 510(k), a genuine design history file, and a defensible post-market compliance programme.
+ companion book included free
Medical Device Compliance CDSCO Registration & Import Licensing | India Market
The complete India medical device compliance guide โ CDSCO registration, import licensing, and post-market obligations under the Medical Devices Rules 2017 from first principles to licensed and audit-ready.
+ companion book included free
Canada Health Canada Medical Device Licensing (Class IIโIV)
The complete practitioner's guide to Health Canada medical device licensing โ from classification and MDSAP through Class II, III, and IV MDL applications, clinical evidence, and post-market obligations.
+ companion book included free