Regulatory Documents
SOTA reports, clinical-evaluation literature modules, Clinical Evaluation Plan support, Post-Market Surveillance documentation, PMCF reports. EU MDR primary; IVDR methodology within reach.
Regulatory·Clinical·Grants
We are workflow specialists for high-value regulatory documents. We produce the literature reviews, SOTA narratives, and evidence synthesis that consume your senior team's capacity, so your team arrives at judgment, not compilation.
This is how our clients work today. AI in the loop, experts in control. You set the strategy. We execute the production. Submission-ready quality.
Scope
We produce, implement, and teach the workflows for high-value documents that share three characteristics: expensive to produce traditionally, expertise-intensive, and quality-critical.
SOTA reports, clinical-evaluation literature modules, Clinical Evaluation Plan support, Post-Market Surveillance documentation, PMCF reports. EU MDR primary; IVDR methodology within reach.
Literature syntheses, systematic reviews, clinical study reports, and adjacent evidence-synthesis work supporting regulatory and scientific submissions.
Research grant proposals and academic submissions that require structured evidence synthesis and rigorous compilation.
SOTA remediation and consistency checks: For inherited SOTA and clinical-evaluation packages, we can screen source-to-claim mapping, terminology drift, traceability gaps, outdated SOTA logic, and cross-document contradictions before they reach notified-body scrutiny.
Division of labor
The division of labor for high-value documentation.
What we are not: regulatory strategy consultants, compliance advisors, or a replacement for your strategic expertise. We stop where strategic regulatory judgment begins. By principle.
Clear roles
Every high-value regulatory document is built from three layers of work. Two are ours to execute. The third is yours by principle.
Literature search, screening, extraction, reference management, formatting. Rule-governed and time-intensive. This is where AI, under expert supervision, delivers the most leverage.
We execute against the scope you set.
Evidence narrative, first-pass appraisal, methodology application, regulatory structure. Skilled expert work. We exercise craft judgment here: search strategy design, appraisal calls, structural decisions that hold up against MEDDEV and MDR expectations. This is what separates our output from a junior writer's or a pure-AI tool's.
We execute, craft judgment included.
Submission pathway, clinical interpretation tied to product-specific context, risk-benefit decisions, equivalence claims, notified body query response. Requires internal knowledge, product history, and strategic intent that no external partner can possess.
Your team. Your consultants. Never us.
Two kinds of judgment run through a SOTA. We make the craft-level calls, the methodology and execution judgments our track record is built on. You make the strategic-regulatory calls, the ones rooted in product knowledge and pathway context. That line is stable and defensible, which is why in-house teams don't feel replaced and consultancies don't feel undercut.
Approach
AI output is not made responsible by placing a human at the end of the workflow. The process has to make review practical: clear task boundaries, visible source context, defined escalation points, and a reviewer qualified to catch the mistakes that matter.
Our model uses AI for the work around the judgment: scaffolding, extraction, evidence mapping, drafting, consistency checks, and review preparation. Clinical interpretation, regulatory strategy, acceptance criteria, benefit-risk implications, and final sign-off stay with qualified humans.
Every human in the workflow has the qualifications to detect the specific mistakes AI makes at their step. No expert is asked to verify work beyond their skill level.
Workflows reward critical thinking, not rapid approval. Reviewers are actively trained on the cognitive demands of AI-augmented review. Oversight is effective, not merely present.
We follow the pace of AI evolution, implementing new capabilities as they arrive and assessing the novel risks they introduce. Adaptability is a core competitive advantage.
Scepticism is part of tool competence. The workflow has to show which tool was used, for which task, under which controls, with which review, and with what audit trail.
Reviewers should see source passages, extracted data, uncertainty, rationale, and task boundaries directly in the review surface. Polished prose is not enough.
Low-risk support tasks can move quickly. Outputs that may influence clinical interpretation, regulatory positioning, or final conclusions are escalated and documented as human decisions.
Our workflows run multiple frontier AI models in parallel on every synthesis task. Their outputs are consolidated and cross-checked against each other, then passed through automated QA covering citation integrity, rule-based checks, and structural consistency, before any human reviewer sees the material.
This is how we operationalize FP2 in practice. By the time clinical and technical specialists engage with the synthesis, it has already been stress-tested by independent AI perspectives and cleared automated gates. Human oversight goes further because the material arriving for review is more consistent and more traceable.
The diagram above is a simplified view. The production pipeline includes additional pre-processing, intermediate QA checkpoints, retrieval and grounding layers, and feedback loops that are omitted here for clarity.
Forward-looking scrutiny
Not because every notified body uses AI to screen SOTAs today. Because systematic, tool-assisted review is a high-probability direction of travel.
SOTAs written now may be reviewed in a more systematic environment within the next 6 to 18 months. Do not write a SOTA today that fails the checks tomorrow's review workflows are likely to run.
Human notified-body review remains essential. The point is to remove inconsistencies that both human reviewers and AI-assisted screening can detect.
Source-to-claim gaps, terminology drift, outdated SOTA logic, traceability gaps, and cross-document contradictions can be surfaced before submission.
AI surfaces issues. Experts decide what can be cleaned up, what needs interpretation, and what must be escalated to manufacturer judgment.
Prepare for your Notified Body's AI. Not by writing for an algorithm. By removing the inconsistencies that both human reviewers and AI-assisted screening can detect.
Evidence
Responsible efficiency for SOTA production, disclosed with full methodology.
Per billable hour, we process approximately 6 pages of appraised source material end-to-end into the final SOTA.*
“End-to-end” spans the full SOTA production pipeline: literature search design, database searches, screening, full-text appraisal, synthesis, drafting, review, and submission-ready formatting. This is the rate for the process as a whole, not for any single step.
* Transparency / methodology
Figures reflect seven representative SOTAs produced through our AI-augmented workflow. Additional SOTAs from the same period are excluded where they are structurally non-comparable (e.g., very narrow re-issues or tightly scoped updates) so these figures reflect end-to-end production work on substantive new SOTAs.
Across these 7 AI-augmented SOTA projects: 600 billable hours, 2,428 literature references processed through our review workflow, resulting in 3,452 pages of appraised source material synthesized into the final SOTA deliverables.
Billable hours reflect the full project pipeline: search design, database searches, screening, full-text appraisal, synthesis, drafting, internal review, and final submission-ready formatting.
Per-project billable hours range from 58 to 120. Per-project rate ranges from 2.6 to 15.8 pages of appraised source material per billable hour, reflecting differences in literature complexity, redundancy, and topic maturity. Final scope for any new engagement is confirmed after initial protocol review.
Earlier pre-AI projects are excluded from this portfolio as they are not representative of current operating efficiency.
We have delivered SOTA reports and clinical-evaluation evidence modules successfully submitted to notified bodies, under client regulatory direction, for medical device companies developing complex, high-risk products. Our methodology is document-category driven, so it applies wherever high-value, synthesis-heavy documents exist.
Who we serve
A · Devices
With complex portfolios facing capacity pressure on senior regulatory, clinical, and quality staff.
B · Consultancies
Needing production capacity without hiring. White-label available. We work under your client relationships and strategic direction, not around them.
C · Scale-ups
Navigating regulatory pathways on tight capital and timelines.
Industries beyond life sciences follow. The workflows apply wherever documents are expensive to produce, standardized in requirements, and synthesis-heavy in execution.
Engagement
Choose how deeply we integrate. Many clients evolve across models as their needs shift.
Done for you
We produce defined document modules and evidence-synthesis deliverables using our AI-augmented workflows. Your team maintains strategic control. Best when you have an immediate document need, capacity constraints on senior staff, or project-based requirements.
Built into your organization
We deploy our AI-augmented workflows inside your organization. You own the system. We provide the processes, tooling integration, and enablement. Best for high document volume and security or IP requirements.
Transfer the capability
We teach your team to produce high-value documents using AI-augmented workflows with expert oversight protocols. Workshop packages, certification programs, and ongoing coaching.
Send us a note about your upcoming submissions and your team's capacity constraints. We'll respond with whether our workflows are a good fit.
Email contact@hvdaccel.comOr connect on LinkedIn.
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