The Independent Technical Review is a defined-scope engagement. For SafeCode's broader certification planning and process strategy services, see certification planning and process strategy. For a lighter-weight diagnostic of an in-progress effort, see the safety-critical software gap scan.
When an outside perspective is not optional
There are points in a safety-critical or high-assurance software program where an independent, experienced external reviewer is not a luxury — it is the only reliable way to know whether what has been built is sound. Internal teams develop blind spots. Assumptions that were reasonable early in development become load-bearing and unexamined. Interfaces that appear clean in isolation create problems at integration. Architecture decisions made under schedule pressure carry risks that only become visible when someone with no stake in the outcome looks carefully.
SafeCode's Independent Technical Review provides that perspective. It is a structured, defined-scope review conducted at a critical program milestone — calibrated to the program's applicable standard, assurance level, and the specific area of greatest technical risk.
What the review covers
The scope of each engagement is defined before work begins. Depending on the program's situation and milestone, a review may focus on one or more of the following areas:
- Architecture and design — whether the software architecture is appropriate for the assurance level, partitioning requirements, and applicable standard; whether design decisions are sound, traceable, and defensible.
- Requirements — whether requirements are complete, unambiguous, and at the appropriate level of detail for the assurance level; whether derived requirements are identified and justified.
- Code and implementation — whether implementation reflects design intent, coding standards are followed, and the code is defensible under formal review.
- Interfaces — whether hardware/software interfaces, inter-component interfaces, and external interfaces are correctly specified and implemented.
- Review readiness — whether the program's artifacts, evidence, and process documentation are in a defensible state for an upcoming formal milestone — DER stage review, FDA submission, notified body audit, or functional safety assessment.
Common questions
What makes this review genuinely independent? Independence means the reviewer has no prior involvement in the development decisions being reviewed, no organizational relationship to the development team, and no stake in a particular outcome. SafeCode conducts reviews as an external party with direct experience in the applicable standard and assurance level — not as an extension of the development team.
When in the program lifecycle is an independent technical review most valuable? The review is most useful at a defined milestone where a consequential decision depends on the technical state of the software — before architecture is locked, before a major integration phase begins, before a formal certification or regulatory review, or after findings have been received and corrective action needs independent validation. It is not a substitute for ongoing technical oversight throughout development.
Which standards does SafeCode support for independent technical review? Reviews are conducted against DO-178C for airborne software, IEC 62304 for medical device software, and IEC 61508 for functional safety software, including relevant technology supplements and domain-specific guidance where applicable. For detailed coverage of certification support within each standard, see DO-178C certification support, IEC 62304 compliance support, and IEC 61508 functional safety software.
How is the independent technical review scoped? Scope is established before work begins based on the program's applicable standard, assurance level, artifact maturity, and the specific area of concern or milestone. SafeCode Consulting will identify what artifacts are needed, what the review will and will not cover, and what the deliverable will include before the engagement starts.
What does the review produce? A written findings report identifying technical risks, gaps, and areas requiring attention, with recommended actions. The depth and format of the report is calibrated to the scope of the engagement and the program's intended use of the findings.
How is an independent technical review different from a certification readiness assessment? An independent technical review is focused on the technical soundness of specific software artifacts at a defined milestone — architecture, design, code, or interfaces. A Certification Readiness Assessment examines the program's overall certification posture — process, planning, evidence readiness, and tooling assumptions — at a broader level. The two engagements address different questions and are often complementary.
Contact SafeCode Consulting to discuss the scope and timing of an independent technical review for your program.