Testing Strategy & Evidence Planning
A testing matrix built by copying similar devices is a common source of both wasted testing and real gaps. FDA-recognized consensus standards let testing reference an established method rather than justify one from scratch, which is why mapping the right standards early matters more than running extra tests against an outdated one.
- Testing matrix recommendation and gap analysis
Most testing matrices are built by working backward from what's commonly done rather than forward from actual risk. We build yours from the device's specific risk profile, then identify what's missing against what a reviewer will expect.
- Performance test design aligned with FDA-recognized standards
Performance testing that doesn't reference a recognized standard invites additional scrutiny by default. We design test protocols against the specific standards FDA has recognized for your device type.
- Sterilization, shelf-life, packaging, and usability testing strategy
These four areas are frequently under-scoped early and become deficiency sources later. We plan them as part of your core evidence strategy from the start, not as an afterthought once the primary testing is done.
- CRO engagement support and report adequacy review
We help you brief testing labs accurately and review what comes back, so results answer the question your submission actually needs answered.
- Labeling review, UDI compliance, and IFU review
Labeling deficiencies are among the most common and most avoidable reasons a submission stalls. We review labeling, UDI compliance under 21 CFR Part 830, and instructions for use against current FDA expectations before submission.
- Applicable consensus standards mapping and Declaration of Conformity
We identify which recognized standards genuinely apply to your device's testing, and prepare the Declarations of Conformity that support your evidence package.