STAGE 05 · VERIFICATION
Prove safety and performance
Generate the bench, preclinical, software, and usability evidence required by the product’s risks and intended claims.
RECOGNIZE THE STAGE
How to know you are here
The design is approaching or has reached a controlled freeze
Formal protocols and acceptance criteria are approved
Testing is intended to support regulatory claims—not only internal learning
READINESS LENSES
What must be managed together
Verification, validation, biocompatibility, electrical, software, usability, animal, or cadaver evidence as applicable.
Use submission-relevant protocols, acceptance criteria, standards, and GLP studies where required.
Seed · Series A · non-dilutive grants. Often $1M–$10M+.
ACTION PLAN
Priorities for the next 90 days
- 01
Freeze the relevant design and test methods
- 02
Confirm protocols and acceptance criteria before execution
- 03
Run the minimum sufficient evidence program tied to risks and claims
- 04
Investigate failures through controlled corrective action
BEFORE YOU ADVANCE
Required outputs
- Verification and validation reports
- Preclinical evidence package
- Human-factors evidence
- Updated residual-risk assessment
WATCH FOR
Common failure modes
- Testing a moving design
- Non-submission-quality methods or records
- Evidence that does not support the proposed claims
THE DECISION GATE
Are the major safety, performance, usability, and manufacturing gaps closed?
Do not advance because time or money has been spent. Advance when the evidence supports the decision.
NEED A COMPANY-SPECIFIC ROADMAP?
Turn this orientation into a milestone plan.
SECUIA can connect product, evidence, regulatory, usability, and financing decisions around your actual technology.
Call SECUIA