Intended Use Documentation Support
Documenting what the software does and does not claim in technical terms, supplying the description your regulatory advisors work from when framing intended use.
Custom Software
Hire FDA AI SaMD Regulatory Consultants
FDA AI SaMD regulatory support means producing the engineering evidence a submission depends on: intended use documentation, verification and validation records, requirements traceability, algorithm change protocols, and post-market monitoring. Taction Software supplies that technical work alongside the regulatory consultants and counsel who own strategy and submission.
Be clear about the division. We are a software engineering firm, not a regulatory consultancy, law firm, or authorized agent. We do not determine classification, select a submission pathway, prepare filings, or communicate with the agency. What we do is build software under documented lifecycle processes so the evidence exists when your regulatory advisors need it. Our hire dedicated developers hub covers implementation roles.
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What This Engineering Work Produces
Submissions rest on evidence generated during development. Reconstructing it afterward is expensive and produces records reviewers reasonably distrust. The work below is what engineering contributes toward a submission your regulatory advisors assemble. Predetermined change control planning appears among these because AI systems that will be updated after clearance need that pathway designed into the software rather than added later.
Requirements Traceability Records
Maintaining links from requirement through design and implementation to verification, produced during development rather than assembled before a submission.
Verification and Validation Evidence
Executing and documenting testing that maps to requirements, including the clinical performance evidence your regulatory strategy specifies.
Algorithm Change Protocol Engineering
Building the technical capability for controlled model updates, including the monitoring and retraining boundaries a predetermined change control approach describes.
Post-Market Monitoring Implementation
Building the production monitoring that ongoing obligations reference, covering performance, drift, and the reporting your regulatory function requires.
Design History and Change Records
Maintaining controlled documentation of decisions, changes, and rationale under a quality system, since reconstruction after the fact undermines the record’s credibility.
Regulatory and Clinical Context This Work Requires
Software intended to inform diagnosis or treatment sits under device regulation, and AI systems raise the additional question of how a model that changes over time remains within its cleared intended use. Engineers need to understand these constraints to build appropriately, without mistaking that understanding for regulatory expertise. The context below spans the healthcare work you assign.
01
Intended Use Determines Everything Downstream
The claim shapes classification, evidence requirements, and pathway. Changing it later invalidates completed work, which makes early settlement with your advisors essential.
02
IEC 62304 Applies Where Software Is a Device
The lifecycle standard applies to medical device software. It does not apply to every hospital or healthcare business system, and applying it indiscriminately adds cost without benefit.
03
Evidence Must Be Contemporaneous
Documentation produced during development is credible. Records assembled before submission invite questions about whether the described processes were actually followed.
04
Model Updates Need a Planned Pathway
AI systems that improve after clearance require a change control approach agreed in advance, with technical capability built to operate within its boundaries.
05
Clinical Performance Requires Study Design
Validation evidence frequently requires clinical study work that is specialist activity outside software engineering and priced entirely separately.
06
We Support, We Do Not Determine
Classification, pathway selection, submission preparation, and agency interaction belong to your regulatory consultants and counsel. We build software and evidence.
Engineering Skills This Work Requires
This is disciplined software engineering under a quality system rather than regulatory practice. The differentiating skill is producing traceable evidence as development proceeds without the process becoming an obstacle to shipping. The competencies below reflect that. Weight lifecycle discipline and documentation habit above regulatory knowledge, which your advisors supply.
Lifecycle Process Execution
Working within documented development processes with design controls, review gates, and records produced as work proceeds rather than compiled afterward.
Requirements Engineering for Testability
Writing requirements that can be verified, since vague specifications produce untestable systems and traceability gaps that surface during review.
Verification Evidence Production
Building automated and manual testing that maps to requirements, with results retained as controlled records suitable for inclusion in a submission.
Risk Control Implementation and Traceability
Implementing software risk controls with links to the hazards they address, so a control is not removed during refactoring by someone unaware of its purpose.
Change Control and Configuration Management
Managing changes to released software with assessment, approval, and reproducible builds, since released versions must be reconstructable years later.
Integration and Deployment Under Control
Deploying into clinical environments with documented configuration. Our healthcare integration work covers that connectivity.
How We Evaluate Engineers for This Work
The distinguishing question is whether they have worked under a real quality system and can describe what they found difficult. Engineers who describe it as straightforward have either not experienced it or did not follow it. Our assessment centers on lifecycle discipline and documentation habit. Our delivery process includes review points where you can reassess fit.
Quality System Experience
We ask which controlled processes they worked within and what artifacts they produced. Specific complaints about a real process indicate genuine exposure.
Traceability Practice
We ask how requirements linked to verification. Engineers without that discipline created gaps that surface during review as questions nobody can answer.
Documentation Under Pressure
We ask what happened to records during a late project. Engineers who abandoned documentation to hit a date created the gaps that undermine a submission.
Risk Control Awareness
We ask about a control they implemented and the hazard it addressed. Engineers unaware of the connection remove controls during refactoring.
Change Assessment Discipline
We ask how released software changes were handled. Engineers accustomed to same-day deployment may find controlled change frustrating rather than expected.
Verified Regulated Experience
We describe which regulated projects each engineer worked on and their role. We do not claim regulatory affairs or quality credentials for engineers.
Engagement Options for Regulated Development
Engagements should be scoped against your regulatory strategy, since intended use and pathway determine what evidence is required. Structures below reflect that. We also raise scope questions early, since organizations sometimes assume device obligations that their stated intended use does not trigger, and the reverse is more dangerous.
Regulatory Strategy Alignment First
Working from your advisors’ intended use and pathway determination, since evidence requirements follow from those decisions rather than from engineering preference.
A Single Engineer Within Your Quality System
Suits organizations with established processes needing additional development capacity that works within existing controls and documentation practice.
Engineer With Verification Independence
Pairing implementation with separate verification produces cleaner evidence than one engineer writing both the code and the tests approving it.
Augmenting Your Regulated Development Team
Where you own the quality system, staff augmentation adds capacity working within your existing procedures and documentation standards.
Full Team for Device Software Programs
A dedicated healthcare development team covering development, verification, and documentation suits programs building device software with sustained regulatory requirements.
Fixed-Scope Component With Evidence
Where a component and its verification obligations are defined, a fixed-scope build under our engagement models delivers it with the documentation package.
Tell Us What Your Regulatory Advisors Have Decided
Share the intended use, pathway, and quality system status your advisors have established. Evidence requirements follow from those decisions rather than preceding them.
Scope Boundaries and What We Do Not Do
Stating limits plainly matters here. We do not determine classification, select pathways, prepare or file submissions, interact with the agency, act as an authorized agent, or guarantee any regulatory outcome. Taction holds no FDA clearance for your product. Where intended use may create diagnostic or treatment claims, SaMD classification is assessed during discovery with your regulatory advisors. We build to HIPAA-aligned practices where HIPAA applies.
01
Classification and Pathway Belong to Your Advisors
Whether software is a device, what class applies, and which pathway fits are determinations made by qualified regulatory professionals rather than by software engineers.
02
We Do Not Prepare or File Submissions
Submission assembly, filing, and agency interaction sit entirely outside our scope. We produce engineering evidence your regulatory function incorporates.
03
No Outcome Is Guaranteed
No vendor can guarantee clearance or approval. We build evidence supporting a submission, and the determination belongs to the agency.
04
Clinicians Retain Clinical Decisions
Software we build supports clinical judgment. It does not diagnose, prescribe, order, or determine treatment independently regardless of its regulatory status.
05
Sensitive Application Handling
Device software touching behavioral health carries additional considerations. We built CHIPSS, a behavioral health system, where such handling was foundational.
06
Claims We Would Not Make
We would not describe our work as regulatory consulting, present evidence production as submission support beyond engineering, or suggest that our involvement affects a regulatory outcome.
Cost to Engage Regulated Engineering Work
Regulated development costs more than equivalent unregulated work, and the difference is documentation, verification, and change control rather than features. Clinical validation studies and regulatory consulting are entirely separate costs. We publish no figures on submission timelines or outcomes, because those depend on your product, pathway, and reviewer.
- 01
MVP or Single Module
$40,000 to $80,000
One bounded component developed under lifecycle process with requirements, traceability, verification evidence, and documentation suitable for inclusion in a submission.
- 02
Full Platform Build
$80,000 to $200,000
Multi-component device software with design controls, verification, risk control traceability, change management, and post-market monitoring implementation.
- 03
Enterprise Deployment
Starting at $200,000
Multi-site deployment with quality system documentation, extended validation support, algorithm change control implementation, and lifecycle management.
- 04
Discovery Phase Scoping
Discovery is paid and time-boxed. It produces a technical assessment against your advisors’ pathway determination, evidence gap findings, and an itemized fixed-scope estimate.
- 05
Cost Drivers to Expect
Intended use complexity, verification depth, risk control scope, algorithm change control requirements, existing quality system maturity, and documentation expectations.
- 06
Ongoing Support Costs
Released device software carries continuing obligations: change assessment, monitoring, periodic reverification, and vulnerability management under change control.
Third-party licensing, cloud infrastructure, data subscriptions, and hardware are separate from engineering cost and itemised clearly.
Clinical validation studies, regulatory consulting, submission preparation, and agency interaction are entirely separate from our scope and cost.
Why Engage Regulated Engineering Through Taction
Two questions matter. Whether the vendor has built software under regulatory registration, and whether they are clear about what they do not do. Taction Software has built healthcare software since 2013, more than twelve years, with over 200 healthcare projects delivered and ISO 27001 certification. Leadership brings more than twenty years of personal experience in the field, which is separate from company age. Our wider case for Taction sits elsewhere.
FDA-Registered Applications We Built
We built Revive Ease and PainKare, both FDA-registered applications. Our healthcare case studies reflect delivery under regulatory registration rather than adjacent experience.
Clinical Platform Depth
We built Voyant Health, an EHR platform. Understanding the clinical systems device software connects to shapes interface design and verification scope.
ISO 27001 Certified Security Management
Taction Software holds ISO 27001 certification covering our information security management practices. It certifies our internal processes and has no bearing on device clearance.
Documentation Produced During Development
Records are generated as work proceeds rather than assembled before submission, which is the difference between credible evidence and a reconstructed package.
We Will Say the Pathway Is Lighter
Where a narrower intended use removes device obligations, we raise it with your advisors. That conversation reduces project scope considerably and is worth having early.
We Will Not Describe Ourselves as Regulatory Consultants
We build software and evidence. Presenting that as regulatory consulting would misrepresent what we do and what you should rely on us for.
FAQs
Frequently Asked Questions
We work from your regulatory advisors’ intended use and pathway determination, assess your quality system status, then present engineers with regulated development experience for your approval.
One component runs $40,000 to $80,000, multi-component device software $80,000 to $200,000, and enterprise deployment starts at $200,000. Clinical studies and regulatory consulting are entirely separate.
Our delivery history includes the Voyant Health EHR platform, the CHIPSS behavioral health system, and the FDA-registered applications Revive Ease and PainKare, within more than 200 healthcare projects delivered since 2013.
No. We produce engineering evidence your regulatory consultants and counsel incorporate. Submission preparation, filing, and agency interaction sit entirely outside our scope.
No. Classification is a regulatory determination requiring qualified professionals. We supply technical description supporting that analysis rather than reaching a conclusion.
That page covers regulated software engineering broadly. This page addresses AI-specific concerns including algorithm change control and the monitoring evolving models require after clearance.
Share the intended use and pathway your regulatory advisors established, your quality system status, your existing documentation, and the engagement model you have in mind. We will produce engineering evidence within our scope and raise where a narrower claim would reduce obligations. We do not provide regulatory consulting or guarantee any outcome.