What's inside this bundle
- ISO 13485:2016 — Medical Devices QMS $350
- EU MDR — Technical File Skeleton $850
- ISO 27001:2022 — Information Security $350
- ISO 14971:2019 — Medical-device Risk Mgmt $450
Who this is for
Class I–III medical-device manufacturers, IVD makers, software-as-a-medical-device (SaMD) companies.
How the discount works
Buying the components individually would cost $2,000. The bundle is priced at $1,600 — a saving of $400 (20% off).
Delivery
All components delivered as editable Microsoft Word + Excel files within 5–7 business days of payment. Implementation guide bundled.