Rebuilding evidence traceability for a generic therapeutic-device dossier
A work case on connecting risks, design requirements, verification, and labelling in a therapeutic-device dossier.
Company and brand names are withheld to protect engagement confidentiality.
Device or product type
A generic therapeutic device with a dossier covering risk management, verification reports, and labelling.
Challenge
Document presence did not show that design requirements and risk controls were covered by traceable evidence and acceptance criteria.
Basier’s work
Basier tested the trace across risks, controls, design requirements, verification protocols and results, and labelling.
Output
A traceability matrix and gap register separating absence, insufficiency, and inconsistency.
What the engagement covered
- Risk register
- Design requirements
- Verification reports
- Acceptance criteria and labelling
What the case shows
Dossier strength comes from relationships across evidence, not isolated document presence.
The case does not demonstrate conformity, dossier acceptance, or an authority outcome for a specific device.