AI/ML Medical Device Documentation Kit – Complete Bundle
€499.00All 10 AI/ML documents + README + Master Index (Excel). One coordinated set, five markets. Save ~28% vs buying individually.
Showing all 5 results

All 10 AI/ML documents + README + Master Index (Excel). One coordinated set, five markets. Save ~28% vs buying individually.

Everything you need to prepare an ANVISA submission — the gap analysis, the essential requirements checklist and the technical dossier pack — in one download, at a saving.

The India toolkit in one download — the CDSCO gap analysis plus the Device and Plant Master File templates — at a saving.

The Saudi Arabia toolkit in one download — the SFDA gap analysis plus the Annex 3 technical documentation kit — at a saving.

Save 20% by buying the Risk Management Documentation Kit and the EU MDR Clinical Documentation Kit together. Fourteen coordinated templates covering both halves of MDR Annex II in one purchase.
MD Regulatory Insights
Stay ahead of the regulatory landscape
Leave your email and stay updated on EU MDR, IVDR, ISO 13485, MDSAP and global market access — plus what it means in practice for your technical documentation.
You're in.
Check your inbox to confirm your subscription — it should arrive within a minute. If you don't see it, have a look in the spam folder.
Added to cart
Check out our shop to see what's available