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Regulatory intelligence service

See what AI is telling your customers about your products.

Your customers are asking AI tools and chatbots questions about your products every day. The answers they get are often wrong, incomplete, or out of date. We test those answers, document the problems, and give your QA, regulatory, and product teams something they can actually work from.

Independent evidence packages built for safety-critical product environments.

Structured regulatory evidence documents on a navy surface.

Evidence-based

Findings written for QA, RA, and PMS review workflows.

Built for regulated, safety-critical product environments

Medical devicesLife sciencesRegulatory affairsQuality assurancePost-market surveillanceCustomer support AI

The problem

Customers are asking AI. The answers may not match your approved product information.

Clinicians, patients, distributors, sales reps, and your own support team all use AI tools when they need a quick answer about a product. Those answers are often incomplete or out of date. Sometimes they contradict your approved labeling, IFU, warnings, or claims. You usually find out when a customer asks why.

Wrong product claims

AI assistants describe your devices confidently and get the details wrong.

Old IFU content showing up

Superseded versions of instructions for use appear in answers and search summaries.

Unsafe usage suggestions

Reuse, off-label, or misuse ideas that contradict your approved labeling.

Wrong region, wrong claim

US claims or availability surface in markets where your product is not cleared.

Distributor chatbot errors

Third-party bots represent your brand with omissions or incorrect specs.

Warnings that disappear

Safety statements get dropped, paraphrased, or softened in generative answers.

Wrong sources surfacing

AI tools pull from low-quality third-party pages instead of your approved materials.

Defect taxonomy

The kinds of AI answer defects we look for.

Findings are grouped into four consistent categories so QA, RA, PMS, and product teams can review, prioritize, and trend issues over time.

See full taxonomy

Safety and clinical risk

  • Unsafe use instructions
  • Missing warnings or contraindications
  • Off-label implications

Regulatory and claim compliance

  • Incorrect product claims
  • Outdated IFU references
  • Regional availability errors

Source quality and information errors

  • Hallucinated specifications
  • Translation drift

Distributor, regional, and chatbot issues

  • Distributor chatbot omissions
  • Poor escalation behavior

Who it's for

For the people who own product information risk.

If a wrong answer about your product creates a safety, regulatory, support, or brand problem for your company, this service is built for you.

Quality Assurance
Regulatory Affairs
Post-Market Surveillance
Product Management
Customer Support
Medical or Clinical Affairs
Distributor and ecommerce channel owners
Cross-functional risk owners

Outcomes

From scattered AI outputs to findings you can act on.

Each AI answer that looks risky becomes a documented finding. It carries a severity rating, the rationale behind it, and a recommended next step. Your team can review it the same way you review any other quality input.

See how it works
  • Catch risky answers early, before they spread
  • Protect customer safety and product trust
  • Feed structured inputs into your PMS process
  • Raise the quality of chatbot and AI responses
  • Prioritize content gaps by actual risk
  • Give QA and RA real evidence, not loose screenshots

What you receive

A structured evidence package, not a folder of screenshots.

Every engagement produces a single, organized package your team can review, prioritize, and route to the right owner.

Tested prompt library

Structured prompts mapped to your products, claims, and risk categories.

AI source and chatbot coverage summary

The public generative engines, AI search overviews, and bots covered in scope.

Captured outputs and screenshots

Reproducible evidence of the answers we observed.

Finding log with severity and rationale

Each finding rated and explained so you can review and prioritize.

IFU, labeling, or claim comparison

Where applicable, observed answers are compared against the materials you provide.

Regional and language flags

Answers flagged where availability, clearance, or claims do not fit the region.

Recommended corrective actions

Practical content, channel, or escalation steps for each finding.

Executive summary and trend reporting

A clear leadership view of risk and how it moves between cycles.

Services

Services built around how regulated teams already work.

All services

Core monitoring services

Most chosen

AI Answer Monitoring

Ongoing testing of public AI tools and generative engines covering product questions, safety information, claims, warnings, and instructions for use.

Chatbot Answer Testing

Independent testing of company, distributor, ecommerce, and customer service bots. We check accuracy, consistency, safety information, and how the bot escalates.

AI Answer Intelligence for Post-Market Surveillance

Recurring reports on AI-generated product answers, repeating question themes, and risk-rated observations. Useful as inputs to PMS review, complaint triage, CAPA discussion, and content updates.

Specialized and add-on services

Regional and Translation Review

We test whether answers shift by country, language, or regulatory context, and flag anything that does not fit the local market.

Source Content Gap Review

We identify the missing, unclear, or outdated source content that tends to produce weak AI answers.

Bot Validation Support

Structured test scripts, acceptance criteria, defect logs, and evidence packages for internal customer-service AI bot validation or release readiness.

Reports support internal review and decision-making. They do not replace required complaint handling, PMS, regulatory, or quality system processes.

Our process

A repeatable program that produces QA-grade evidence.

Four steps. Each one builds on the last, from scope to traceable finding.

  1. 01

    Define scope

    We agree on product families, regions, AI tools, chatbot channels, and the question categories that matter most for risk.

  2. 02

    Test real-world prompts

    We run a structured set of prompts drawn from real customer, clinician, distributor, and support situations.

  3. 03

    Classify and prioritize

    Each answer defect is rated for severity, likelihood, safety relevance, regulatory impact, and business risk.

  4. 04

    Report and improve

    You get the report with screenshots, findings, ratings, recommended actions, and trend tracking across cycles.

What makes us different

Visibility is not the same as assurance.

Generic SEO and GEO agencies help you get mentioned. We look at the answer itself and ask whether it is accurate, safe, current, and useful as evidence.

Generic SEO/GEO
Answer Assurance
  • Visibility ranking
    Accuracy, safety, and product information risk
  • Marketing screenshots
    Evidence packages QA and RA can actually use
  • Generic content
    Alignment with IFU, labeling, and approved claims
  • Volume metrics
    Risk-based prioritization
  • Marketing reporting
    Inputs your PMS process can review
  • Single-region focus
    Regional and language context
  • Brand mentions
    Chatbot and AI answer testing

Illustrative examples only

What an AI Answer Audit can uncover.

Every finding lists the prompt tested, the channel where the answer appeared, the issue we observed, a risk rating, and a recommended action. The rows below are illustrative.

Prompt testedChannel testedObserved issueRisk levelRecommended action
Can I reuse this disposable device?Public AI AssistantAnswer implied reuse was acceptable despite single-use labeling.HighUpdate source content and monitor recurring prompts
What warnings apply to this product?Distributor ChatbotBot omitted a key contraindication listed in approved labeling.HighEscalate to chatbot owner and revise knowledge base
Is this product available in Canada?Search AI OverviewAnswer referenced US availability only; no regional clarification.MediumImprove regional product page structure
How do I clean the reusable handle?Public AI AssistantCleaning steps summarized an outdated IFU revision.MediumRefresh public IFU and structured data

Illustrative examples. Actual findings depend on engagement scope, products tested, and AI sources covered.

Packages

Engagements sized to your program.

Three structured tiers and a set of focused add-ons. Every engagement is scoped to your product portfolio and regulatory context.

Start here

Starter AI Answer Audit

A focused review of one product family across selected prompts and major AI sources. A practical way to see where the real risks sit before committing to ongoing monitoring.

Scoped engagement

  • One product family in scope
  • Selected prompts across key risk categories
  • Major public AI answer sources
  • Risk-rated findings report
Request audit
Most chosenRecommended

Monthly Monitoring Retainer

Ongoing AI answer monitoring for teams that need to keep track of risk across product families, channels, and recurring customer questions.

Monthly engagement

  • Recurring prompt testing across cycles
  • Trend, risk score, and movement reports
  • Regional and chatbot spot checks
  • Recommended content and escalation actions
  • Quarterly executive summary
Start monitoring
Enterprise

Regulated Intelligence Program

For mature QA, RA, PMS, or support teams running at scale across regions and channels.

Custom quote

  • Multi-region monitoring
  • Chatbot testing and validation
  • PMS-aligned reporting
  • Source content review
  • Executive summaries
Talk to us

Add-ons

Additional product familiesAdditional regions or languagesDistributor and ecommerce chatbot testingCustom prompt library developmentBot validation supportExecutive reportingRemediation planning

Scope depends on your product families, regions, languages, channels, source materials, and internal review needs.

Fix risky AI answers before they reach more customers.

Request a focused AI Answer Audit. You will receive a risk-rated report covering accuracy, safety, regional fit, chatbot behavior, and content gaps.

About

Visibility is easy. Confidence in the answer is the hard part.

Answer Assurance was built for companies that need more than tracking where they appear in AI tools. They need confidence that the answers being produced are accurate, safe, current, and consistent with what regulated products require.

We combine independent AI answer testing with the structured thinking quality and regulatory teams already rely on: risk-based assessment, traceable evidence, and remediation recommendations that fit how your team already works.

  • AI answer testing
  • Quality and regulatory thinking
  • Risk-based assessment
  • Structured reporting
  • Practical remediation recommendations

FAQ

Frequently asked questions.

Have something specific to your portfolio? We are happy to walk through it.

hello@answerassurance.com
What is AI answer monitoring?

It is the practice of testing what AI tools, search assistants, and chatbots actually say when someone asks about your products. That includes claims, safety information, instructions for use, and regional availability.

Is this the same as SEO or GEO?

No. SEO and GEO are about visibility and ranking. We focus on whether the answer itself is accurate, safe, and current. Two different problems.

What AI tools do you test?

Major public generative engines, AI search overviews, AI chat assistants, and the customer-facing, distributor, or ecommerce chatbots that fall within your engagement scope.

Can you test our customer service chatbot?

Yes. We provide independent test scripts, defect logs, and evidence packages that fit into release readiness or validation activities.

Can this support post-market surveillance?

Our reports give your team structured inputs that may inform PMS, complaint triage, and CAPA discussions. They do not replace required complaint handling, PMS, regulatory, or quality system processes.

Do you review answers against our IFU or approved labeling?

Yes. You provide the approved materials and we assess observed answers against them, with clear traceability in the finding log.

Can you monitor different countries or languages?

Yes. Regional and translation review is a core capability and is scoped per country, language, or regulatory context.

What do reports include?

The prompts we tested, the AI channels we covered, the answers observed, screenshots, risk classifications, recommended actions, and trend tracking across cycles.