We are the execution layer for the teams who own critical biomedical documents. You keep the strategy, the interpretation, and the sign-off. We run the production workflows behind regulatory, clinical, and grant documents, so your senior people arrive at judgment, not compilation.
Most teams reach for help once the deadline is already real. We mobilize quickly, structure the work, and move literature review, SOTA analysis, or remediation forward when it is already on the critical path.
Multi-step, AI-augmented checks for source-to-claim gaps, terminology drift, traceability weaknesses, and cross-document contradictions — before a notified body or a future screening workflow sees them.
Accelerated intake, gap analysis, and issue triage — so you can see the shape of the problem in days and make a better scope decision.
SOTA reports, clinical-evaluation literature modules, CEP support, PMS 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, deadline-disciplined compilation.
Literature search, screening, extraction, reference management, formatting. Rule-governed and time-intensive. This is where AI, under expert supervision, delivers the most leverage.
Evidence narrative, first-pass appraisal, methodology application, regulatory structure. We exercise craft judgment here — search strategy design, appraisal calls, structural decisions that hold up against MEDDEV and MDR expectations.
Submission pathway, clinical interpretation tied to product-specific context, risk-benefit decisions, equivalence claims, notified body query response. Requires internal knowledge and strategic intent no external partner can possess.
"Two kinds of judgment run through a SOTA. We make the craft-level calls our track record is built on. You make the strategic-regulatory calls rooted in product knowledge and pathway context. That line is stable and defensible — in-house teams don't feel replaced, and consultancies don't feel undercut."
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.
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. Not by writing for an algorithm — by removing the inconsistencies that both human reviewers and AI-assisted screening can detect. Documentation built for the review it will actually meet.
A bounded, fixed engagement that screens your existing SOTA or clinical-evaluation file and returns fast first findings: source-to-claim gaps, terminology drift, traceability weaknesses, cross-document contradictions. Findings, not conclusions — anything needing clinical interpretation stays with your regulatory experts.
Every AI-assisted step in our production workflows lands in front of a human reviewer, and every review decision is recorded inside the workflow itself.
Corrections are graded by severity and tracked per task type. The result is a production system whose quality is inspectable rather than asserted, in a form conservative reviewers can interrogate.
We publish no performance numbers that have not passed those gates. What we can say plainly: 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 standing workflow evaluation shows recorded correction rates during mandatory human review have fallen sharply since spring 2026. Two things changed at once: a new model generation arrived, and we rebuilt our workflow harness around self-correcting loops with adversarial checking. The gain comes from both factors together, not from the models alone.
Verification is unchanged: every deliverable passes full human expert review. What dropped is how much correction that review requires, and with it the billable hours a verified document takes. We bill effort, so that saving passes straight to our clients. Increased protection against detectable inconsistencies, not guaranteed acceptance.
How we count: denominators are recorded human review decisions in our workbooks; a correction means a reviewer changed the AI-prepared result, and cosmetic edits count as accepted. Grounding figures are residuals from automated source checks that run before human review. Figures are per task type, never blended. One construct, marked corrections in article summaries during human review, held roughly steady under a fuller review protocol, so we do not claim uniform improvement across every task. Lower correction rates mean increased protection against detectable inconsistencies, not guaranteed acceptance.
With complex portfolios facing capacity pressure on senior regulatory, clinical, and quality staff.
Production capacity without hiring. White-label available — we work under your client relationships and strategic direction, not around them.
Navigating regulatory pathways on tight capital and timelines.
We produce defined document modules and evidence-synthesis deliverables using our AI-augmented workflows. Your team maintains strategic control. A bounded scrutiny report is the recommended first envelope.
We deploy our AI-augmented workflows inside your organization. You own the system; we provide processes, tooling integration, and enablement. Best for high volume and security or IP requirements.
We teach your team to produce high-value documents using AI-augmented workflows with expert oversight protocols. Workshops, 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.comAlready have a SOTA or CER file? Ask about a bounded Pre-Submission Scrutiny Report.
Working on an evidence-heavy grant proposal? Ask about grant workflow capacity. Or connect on LinkedIn.