AI System Inventory and Scope Assessment
Identifying which of your AI systems may fall within scope, including capability inside purchased products, as input to the classification analysis your counsel performs.
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Hire EU AI Act Consultants for Healthcare
EU AI Act consultants help healthcare organizations understand how the regulation may apply to their AI systems and prepare the technical evidence its obligations reference. They assess system classification questions, identify documentation and monitoring gaps, and build the artifacts that support conformity work led by your regulatory advisors.
Taction Software is a software engineering firm. We are not a law firm, notified body, or authorized representative, and we do not provide legal advice or make regulatory determinations. Classification and conformity conclusions require EU-qualified legal and regulatory counsel. What we contribute is technical assessment and the engineering artifacts obligations depend on. Our hire dedicated developers hub covers implementation roles.
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What This Work Produces
The regulation places obligations on providers and deployers of AI systems, with heavier requirements where systems fall into higher risk categories. Much of what it references is technical: risk management, data governance, logging, transparency, human oversight, and accuracy documentation. The work below reflects what engineering can supply toward that. Legal conclusions remain with your counsel throughout.
Technical Documentation Preparation
Producing the system descriptions, development records, and performance documentation that obligations reference, in a form your regulatory advisors can use.
Data Governance Documentation
Documenting training and validation data provenance, characteristics, and known limitations, which is where organizations most frequently find records were never kept.
Logging and Traceability Implementation
Building the record-keeping that automatic logging obligations reference, retained appropriately and structured for the retrospective examination they anticipate.
Human Oversight Design and Documentation
Documenting where human review sits, what information reviewers receive, and how they can intervene, since oversight must be effective rather than nominal.
Accuracy, Robustness, and Monitoring Evidence
Producing performance documentation including subgroup results and post-deployment monitoring arrangements the regulation’s ongoing obligations reference.
Regulatory and Healthcare Context This Work Requires
Healthcare AI sits in a complicated position under this regulation because medical device rules and AI rules interact, and systems already under device regulation face layered obligations. That interaction is a legal analysis rather than an engineering one. What engineering determines is whether the evidence those obligations reference exists. The context below spans the healthcare work you assign.
01
Scope Depends on Market Placement
Obligations attach to systems placed on or used in the EU market. Whether your deployment falls within scope is a legal question your counsel answers, not an engineering assumption.
02
Medical Device Rules Interact With AI Rules
Systems already regulated as medical devices face layered requirements. Understanding that interaction requires EU regulatory expertise rather than software engineering judgment.
03
Obligations Reference Evidence That Must Exist
Documentation requirements assume records were kept during development. Organizations that did not keep them face reconstruction that reviewers reasonably distrust.
04
Human Oversight Must Be Effective
Nominal review satisfies nothing. Documentation must describe what reviewers see, what they can do, and whether the workflow makes meaningful intervention possible.
05
Timelines and Guidance Continue to Evolve
Implementation timelines, guidance, and harmonized standards have developed over time. Current status must be confirmed with counsel rather than assumed from any summary.
06
Preparation Is Not Conformity
Building technical evidence supports conformity work. It does not establish conformity, which involves assessment processes we neither perform nor certify.
Skills and Methods This Role Requires
This work requires enough regulatory literacy to know which evidence obligations reference, combined with the engineering capability to produce it. A consultant offering legal conclusions is exceeding what a software firm should provide. The competencies below reflect that. Weight technical documentation capability and honest scoping above regulatory opinion.
Technical Documentation Production
Producing system descriptions, architecture records, and development documentation in forms regulatory advisors can assess and submit.
Data Provenance Reconstruction and Recording
Documenting training and validation data sources, characteristics, and limitations, including honest acknowledgment where records were not kept.
Logging and Retention Implementation
Building automatic record-keeping with appropriate retention and structure. Our healthcare integration work covers connectivity where logging touches clinical systems.
Human Oversight Assessment
Evaluating whether review is meaningful in practice, including whether reviewers have time and information to intervene rather than approving reflexively.
Performance and Subgroup Documentation
Producing accuracy and robustness evidence including performance across populations, which is a technical exercise requiring evaluation infrastructure.
Coordination With Regulatory Counsel
Working alongside your legal and regulatory advisors, supplying technical input to their analysis rather than substituting engineering judgment for it.
How We Evaluate Consultants for This Work
The distinguishing question is where they stopped. Consultants offering classification conclusions exceeded appropriate scope for a software firm. Our assessment centers on technical documentation capability and clear boundaries about what they do not determine. Our delivery process includes review points where you can reassess fit.
Where They Deferred to Counsel
We ask which questions they referred to legal advisors. Consultants offering classification opinions exceeded what a software engineering firm should provide.
Documentation Gaps They Found
We ask what records did not exist. Consultants reporting complete documentation either found unusually mature practice or did not examine closely.
Data Provenance Handling
We ask how they documented training data. Organizations frequently lack these records, and honest acknowledgment serves better than reconstructed approximation.
Human Oversight Assessment
We ask how they evaluated review effectiveness. Documenting that a reviewer exists differs from establishing that review is meaningful at realistic volume.
Logging Implementation Experience
We ask what record-keeping they built. Consultants who only advised did not confront the retention and structure decisions logging obligations imply.
Verified Advisory Experience
We describe which programs each consultant supported and what was produced. We do not claim legal, notified body, or regulatory credentials for consultants.
Engagement Options for This Work
Engagements should be scoped alongside your regulatory counsel, since the legal analysis determines what technical work is required. Structures below reflect that. We also assess whether scope questions are settled, because building evidence for obligations that may not apply wastes effort your counsel could prevent.
Technical Gap Assessment
Examining what documentation, logging, and performance evidence exists against what obligations reference, delivered as input to your counsel’s analysis.
Documentation Production Engagement
Producing technical documentation, data governance records, and performance evidence in forms your regulatory advisors can assess and use.
Logging and Monitoring Implementation
Building the record-keeping and post-deployment monitoring obligations reference, which is engineering work regardless of how classification resolves.
Augmenting Your Regulatory Function
Where you have regulatory expertise, staff augmentation adds technical capacity working under your direction and interpretation.
Full Team for Regulated AI Programs
A dedicated healthcare development team builds capabilities with documentation and logging produced during development rather than reconstructed afterward.
Fixed-Scope Documentation Deliverable
Where requirements are defined by your counsel, a fixed-scope engagement under our engagement models delivers the technical evidence package.
Tell Us What Your Counsel Has Determined
Share your counsel’s scope and classification analysis, your EU market position, and your AI systems. Legal analysis determines what technical work is actually required.
Advisory Limits, Legal Boundaries, and What We Do Not Do
This section states our limits plainly. We do not provide legal advice, make classification determinations, act as an authorized representative, or perform conformity assessment. We are not a notified body and cannot certify anything. 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 Belongs to Your Counsel
Whether a system falls within scope and which risk category applies are legal determinations. We supply technical input to that analysis rather than reaching conclusions.
02
We Do Not Certify or Assess Conformity
Conformity assessment involves processes we neither perform nor participate in. Our work produces technical evidence supporting whatever route your advisors determine.
03
Current Requirements Must Be Confirmed
Implementation timelines and guidance continue to develop. Current obligations should be confirmed with counsel rather than taken from any summary including ours.
04
Documentation Gaps Reported Honestly
Where development records were not kept, we say so rather than reconstructing approximations that a reviewer would reasonably question.
05
Sensitive Application Attention
Systems touching behavioral health carry additional considerations. We built CHIPSS, a behavioral health system, where such handling was foundational.
06
Positions We Would Maintain
We would not offer legal conclusions, present technical preparation as conformity, reconstruct development records as though contemporaneous, or describe any assessment as certification.
Cost to Engage Technical Preparation Work
Cost concentrates in documentation production and logging implementation rather than advisory time. Where development records were not kept, reconstruction is expensive and produces weaker evidence than contemporaneous documentation would have. We publish no figures on conformity outcomes, because those depend on assessment processes we do not participate in.
- 01
MVP or Single Module
$40,000 to $80,000
Technical documentation, logging implementation, and performance evidence for one AI system, produced as input to your counsel’s conformity work.
- 02
Full Platform Build
$80,000 to $200,000
Documentation and logging across an AI portfolio with data governance records, human oversight documentation, monitoring implementation, and evidence packages.
- 03
Enterprise Deployment
Starting at $200,000
Multi-system preparation with governance integration, documentation standards, and logging infrastructure across several clinical environments and deployments.
- 04
Discovery Phase Scoping
Discovery is paid and time-boxed. It produces a technical gap assessment against obligations your counsel has identified, prioritized findings, and an itemized fixed-scope estimate.
- 05
Cost Drivers to Expect
System count and complexity, existing documentation state, data provenance record availability, logging implementation scope, monitoring requirements, and coordination with regulatory advisors.
- 06
Ongoing Support Costs
Post-deployment obligations continue. Budget for monitoring operation, documentation maintenance as systems change, and updates as guidance and standards develop.
Third-party licensing, cloud infrastructure, data subscriptions, and hardware are separate from engineering cost and itemised clearly.
Conformity assessment, legal advisory, and notified body engagement are entirely separate from our scope and cost.
Why Engage Technical Preparation Through Taction
Two questions matter. Whether the vendor stays within appropriate scope, and whether they report documentation gaps honestly. 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.
Experience Under Regulatory Registration
We built Revive Ease and PainKare, both FDA-registered applications. Our healthcare case studies reflect producing documentation under regulatory attention.
Clinical Systems Built From the Inside
We built Voyant Health, an EHR platform, and CHIPSS, a behavioral health system, which informs how documentation and oversight should reflect clinical reality.
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 AI regulation conformity.
Documentation Produced During Development
Where we build the system, records are produced as work proceeds rather than reconstructed, which is the difference between defensible evidence and an assembled package.
We Stay Within Our Scope
We do not offer legal conclusions or classification determinations. That limits what we sell and keeps you from relying on engineering judgment for legal questions.
We Report Missing Records Plainly
Where development documentation was never kept, we say so rather than reconstructing plausible approximations that a reviewer would reasonably question.
FAQs
Frequently Asked Questions
We work from your counsel’s scope analysis, assess what documentation and logging exist, then present consultants with regulated healthcare software experience for your approval.
One system runs $40,000 to $80,000, portfolio preparation $80,000 to $200,000, and multi-system programs start at $200,000. Legal advisory and conformity assessment 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. Classification is a legal determination requiring EU-qualified counsel. We supply technical input to that analysis and do not reach conclusions about scope or category.
No. We are not a notified body and do not perform conformity assessment. We produce technical evidence supporting whatever route your regulatory advisors determine.
Governance work builds your internal decision and oversight process. This page addresses technical preparation referencing one specific regulation, alongside counsel who determines what applies.
Share your counsel’s scope and classification analysis, your EU market position, your AI systems and their documentation state, and the engagement model you have in mind. We will produce technical evidence within our scope and report missing records honestly. We do not provide legal advice, certification, or conformity assessment.