Launch FDA-Compliant Software | Without Guesswork, Rework, or “Hope-Based” Claims
We help digital health teams determine if they’re regulated, pick the fastest defensible pathway (510(k), De Novo, PMA when applicable), build the right documentation (IEC 62304, ISO 14971, usability, cybersecurity), and package a submission that matches how FDA reviews software.
Why SaMD Programs Stall (Even with Great Engineering)
FDA doesn’t “approve an app” — it evaluates intended use, clinical risk, software lifecycle controls, cybersecurity posture, and evidence that the software performs as claimed in the target population and workflow. Teams lose months when claims drift, predicates are mismatched, validation isn’t traceable, or documentation is “built after.”
- Claims drive classification: one sentence can shift you from wellness → regulated device.
- Wrong predicate = wrong submission: “similar features” isn’t substantial equivalence.
- 62304 + 14971 must connect: hazards, controls, verification, and validation must trace cleanly.
- Cybersecurity is review-critical: threat modeling, SBOM, patching, and secure design are expected.
- Clinical validation is not optional: the higher the risk, the more “real-world” performance matters.
SaMD / Digital Health Services
Modular engagements with clear artifacts, realistic timelines, and pricing bands.
SaMD Triage (Device Determination + Pathway)
Typical range: $4,500–$12,000
For teams needing a fast, defensible answer: regulated or not, and what FDA route makes sense.
- Device vs general wellness determination + claim cleanup
- Classification hypothesis + likely pathway (510(k) vs De Novo vs other)
- High-level evidence map (V&V, clinical, usability, cybersecurity)
Predicate Search & Substantial Equivalence Strategy
Typical range: $7,500–$18,000
For 510(k)-oriented SaMD that needs a tight predicate fit and a review-friendly comparison narrative.
- Predicate shortlist + rationale (intended use, indications, inputs/outputs, workflow)
- 510(k)-ready comparison matrix outline (features, performance, risks, differences)
- Testing plan keyed to differences (software, clinical, usability, cybersecurity)
Q-Sub / Pre-Sub Package (Digital Health)
Typical range: $9,500–$24,000
For teams that want FDA alignment before burning cycles on the wrong validation plan.
- Meeting objectives + targeted questions that force clear answers
- Device description, intended use/indications, workflow + architecture summary
- Proposed V&V and clinical validation plan + risk/cybersecurity summary
Software Lifecycle Documentation (IEC 62304 + Traceability)
Typical range: $12,000–$35,000
For teams that need an “inspection-ready” software file that maps to how FDA reviews software.
- Software Development Plan + SOUP/open-source controls + release process
- Requirements → design → verification traceability support
- Verification summary pack aligned to risk and claims
Risk Management + Usability (ISO 14971 + IEC 62366-1)
Typical range: $9,500–$28,000
For teams needing defensible hazard analysis, human factors, and validation that match clinical workflow.
- Hazard analysis + risk control measures tied to software requirements
- Use-related risk analysis + critical tasks and validation planning
- Risk/Usability summaries packaged for submissions
Cybersecurity & Interoperability (FDA-Ready)
Typical range: $9,500–$30,000
For connected SaMD that must demonstrate secure design, maintenance readiness, and safe data exchange.
- Threat modeling + security architecture narrative
- SBOM support + vulnerability/patching + update strategy
- Interoperability assumptions, interfaces, and validation approach
510(k) Submission Authoring (SaMD)
Typical range: $25,000–$75,000 (scope-dependent)
For teams ready to compile, polish, and submit a complete digital health submission package.
- Core sections authoring + testing summaries integration
- Labeling / IFU / claims alignment with evidence
- Interactive review support + response strategy
De Novo Strategy & Submission Support (SaMD)
Typical range: $45,000–$140,000 (scope-dependent)
For novel SaMD where classification, controls, and validation must be built from first principles.
- Classification & special controls strategy + evidence roadmap
- Pre-Sub alignment + De Novo authoring support
- Risk controls + post-market/maintenance commitments planning
Who We Help
AI/ML Decision Support
SaMD that influences clinical decisions and must prove performance, bias controls, and safe use conditions.
Remote Monitoring & Diagnostics
Systems ingesting signals/data where validation, labeling, and interoperability assumptions must be explicit.
Digital Therapeutics (DTx)
Therapeutic software requiring outcomes evidence, protocol discipline, and review-ready documentation.
Connected Devices + Companion Apps
Accessories/controllers and patient apps that must align cybersecurity + usability + software lifecycle controls.
Health Platforms & EHR Integrations
Products where data exchange, interfaces, and clinical workflow validation determine safety and effectiveness.
Teams Under Time Pressure
Investor timelines that demand speed—earned through a clean pathway and strong evidence mapping.
How We Run SaMD Engagements
The fastest route is the one you don’t have to redo.
Claims & Intended Use
We tighten claims, indications, and user/workflow so the regulatory frame doesn’t drift mid-build.
Pathway & Evidence
We map pathway, predicate/controls, and the V&V/clinical/usability/cybersecurity evidence package.
Documentation & Traceability
We build submission-ready artifacts that connect risks → requirements → verification → validation.
Q-Sub / 510(k) / De Novo
We package the story, align with FDA feedback, and support interactive review through clearance.
SaMD / Digital Health FAQs
Is our product “general wellness” or a regulated medical device?
It depends on intended use and claims (including implied claims), and whether the software is intended to diagnose, treat, prevent, mitigate, or affect the structure/function of the body. We run a fast device determination and provide a defensible rationale.
Do we need a 510(k) or a De Novo?
If there’s a suitable predicate with the same intended use and similar technological characteristics, 510(k) may fit. If not, De Novo may be required to establish a new classification and controls. We map both options and recommend the fastest defensible route.
What are the “must-have” standards and documentation for SaMD?
Most SaMD programs must address software lifecycle controls (often IEC 62304), risk management (ISO 14971), usability/human factors (IEC 62366-1), and cybersecurity expectations (threat modeling, maintenance readiness, SBOM where applicable).
How much clinical evidence do we need?
It depends on risk, claims, novelty, and how the software impacts clinical decisions. Many SaMD products need clinical validation in the intended population/workflow—especially if outputs are diagnostic, predictive, or treatment-influencing.
Are these pricing ranges fixed?
No—these are typical working bands. After a short triage we can provide a fixed or milestone quote based on pathway, risk class, software complexity (including AI/ML), and the amount of V&V, cybersecurity, and clinical validation support required.
Request SaMD Triage
Send your product summary, intended use/claims, target users, and current build stage. We’ll reply with the likely pathway, key evidence gaps, and a milestone quote.