Sequence

Ten years, in order

Do not buy year-8 equipment in year 1. The casting cell, the NDA door, and two billed services come first. A Class I file comes only after an article is named.

1. 1 Open the door

   Invoice services and non-device models. No EDA device file yet.

   • MDR-01-01 Patient-specific vascular planning model
   • MDR-01-02 Family-consent heart model, 1:1
   • MDR-01-03 Aneurysm and stenosis rehearsal inserts
   • MDR-01-04 Lost-core silicone vessel phantom
   • MDR-01-05 Positioning jig and organizer prototypes
   • MDR-01-06 Booked training day
   • MDR-01-07 Pain-point observatory, one quarter
   • MDR-01-08 Disclosure, NDA and prior-art clinic

2. 2 Build the library

   Anatomy sets, inserts, and the first utility-model filings.

   • MDR-02-01 Circle of Willis clear phantom
   • MDR-02-02 TAVI landing-zone set
   • MDR-02-03 LAD lesion library
   • MDR-02-04 Four-chamber heart, 1:1
   • MDR-02-05 Utility-model pack for jigs
   • MDR-02-06 Competency booklet

3. 3 First licence

   One jig family licensed. A pulsatile bench you can book. CHD on retainer.

   • MDR-03-01 First jig-family licence
   • MDR-03-02 Pulsatile bench session
   • MDR-03-03 CHD planning retainer
   • MDR-03-04 Ventricular chamber phantom
   • MDR-03-05 Revenue-share workshop
   • MDR-03-06 Consumable-substitution trio

4. 4 Larger anatomy

   Aorta to runoff, venous and dialysis models. Industry bench days. QMS drafted.

   • MDR-04-01 Aorto-iliac and AAA construct
   • MDR-04-02 Iliac–femoral runoff model
   • MDR-04-03 Dialysis-access planning model
   • MDR-04-04 Industry deployment bench day
   • MDR-04-05 Class I quality-system draft
   • MDR-04-06 Iliofemoral venous model

5. 5 Name a Class I

   File one non-sterile Class I article. Export training crates. Radiopaque only if a material qualifies.

   • MDR-05-01 Named Class I organizer
   • MDR-05-02 Export training crate
   • MDR-05-03 Radiopaque phantom pilot
   • MDR-05-04 Anonymized hemodynamic dataset
   • MDR-05-05 Insert system, version 1
   • MDR-05-06 Combined root and coronary kit

6. 6 The twin, on screen

   Non-diagnostic planning software and a modular arterial tree.

   • MDR-06-01 Modular arterial tree
   • MDR-06-02 MEDRA Twin viewer
   • MDR-06-03 Human-in-the-loop segmentation
   • MDR-06-04 Tool-shadow kit
   • MDR-06-05 Aortic root, leaflet set v2
   • MDR-06-06 Design-history record template

7. 7 Teach the method

   A five-course academy other hospitals can buy.

   • MDR-07-01 Five-course academy
   • MDR-07-02 Structural deployment rehearsal set
   • MDR-07-03 Co-development slot
   • MDR-07-04 CHD morphology library
   • MDR-07-05 Matched test-section study
   • MDR-07-06 Train-the-trainer record

8. 8 Make for others

   Contract phantoms for national firms. One CE-intent technical file, not a CE mark.

   • MDR-08-01 Contract phantom manufacture
   • MDR-08-02 CE-intent technical file, one family
   • MDR-08-03 Structural catalogue, consolidated
   • MDR-08-04 Sterile-packaging study
   • MDR-08-05 Lost-core know-how dossier
   • MDR-08-06 Joint design sprint

9. 9 Leave Alexandria

   A MENA licence of the training method. Know-how stays with the university company.

   • MDR-09-01 Training-method centre licence
   • MDR-09-02 University know-how licence
   • MDR-09-03 De-identified anatomy library
   • MDR-09-04 Training crate, version 2
   • MDR-09-05 Segmentation retainer
   • MDR-09-06 Industry observer membership

10. 10 Reference lab

    Membership, an evaluation bench, and a counsel-led spin-out under Law 23/2018.

    • MDR-10-01 Reference-lab membership
    • MDR-10-02 Spin-out briefing, Law 23/2018
    • MDR-10-03 Device-evaluation bench
    • MDR-10-04 Portfolio licence bundle
    • MDR-10-05 National substitution report
    • MDR-10-06 AEDTH method manual, licensed