MedTechLearning.com · MTL-607

Building the Evidence Case for Digital Medication Support — worksheet

Edit the right-hand cells, then print or save to PDF to retain your work. Entries are not saved automatically. Use fictional or anonymised examples.

Complete one worksheet per claim or candidate.
Claim ID, wording and proposed audience	Enter your plan here.
Medicine, device, software and service boundary	Enter your plan here.
Intended use, population, users and jurisdiction	Enter your plan here.
FDA PDURS scope rationale and separate device assessment	Enter your plan here.
NICE pathway / other payer context (if applicable)	Enter your plan here.
Causal chain and assumptions	Enter your plan here.
Technical evidence package and acceptance criteria	Enter your plan here.
Comparator, allocation and common endpoint ascertainment	Enter your plan here.
Primary endpoint, estimand, meaningful effect and follow-up	Enter your plan here.
Safety, burden, quality of life and economic outcomes	Enter your plan here.
Analysis, sample size, missingness and sensitivity analyses	Enter your plan here.
Evidence gap, owner, due date and decision gate	Enter your plan here.
Permitted claim, residual uncertainty and lifecycle review	Enter your plan here.

Planning aid · 24 October 2026 · MTL-607 — Return to the module