Qualification overhead scales faster than delivery
Validation packages stay manual while AI use cases multiply, creating release risk and review bottlenecks.
Validate GenAI for regulated life sciences without slowing releases.
Attestia helps pharma and medical device teams prove AI systems are fit for use with risk-stratified validation, evidence bundles, and human-review workflows.
AI delivery slows down when validation stays manual.
Teams across regulated life sciences face the same pattern: release pressure rises while qualification, documentation, and audit readiness remain fragmented.
Generic AI tools do not satisfy quality teams
Quality and regulatory stakeholders need traceable acceptance criteria, not black-box outputs.
Audit readiness is still reactive
Teams scramble for evidence late in the cycle instead of generating auditable artifacts continuously.
A validation workflow built for regulated AI use cases.
Attestia combines controlled model operations with risk-based evaluation and clear evidence outputs that quality teams can inspect.
Frozen Model Strategy
Pin model versions and deployment context to preserve qualification integrity over time.
Risk-Stratified Evaluation Pipeline
Validate use-case performance against thresholds matched to risk class and intended use.
Audit-Ready Evidence Bundle
Generate timestamped outputs that capture inputs, model metadata, pass/fail decisions, and reviewer sign-off.
One product, two buying centers.
Attestia is designed for both internal quality organizations and external AI vendors shipping into regulated environments.
For Quality & Validation Teams
- Standardize validation criteria across pharma and med device AI use cases.
- Keep humans in control with review checkpoints and clear accountability.
- Produce inspection-ready documentation without rebuilding the package manually.
Start with one bounded workflow, expand with evidence.
Pilot a single high-signal process first, then scale once validation criteria and reviewer workflows are stable.
Classification Support
Validate AI-assisted triage flows for deviations, CAPA themes, or complaint categories.
Document Generation Validation
Check AI-generated text blocks against approved references before inclusion in regulated documents.
Risk Assessment Support
Generate and review structured risk statements mapped to intended use and control measures.
DHF and Software Change Evidence
Support Design History File updates and software change evidence packages for medical device workflows.
A practical pilot path from scope to evidence.
01
Pilot Scoping Call
Define one high-value use case, current constraints, and success criteria.
02
Pilot Setup
Configure model boundaries, validation dataset, thresholds, and review ownership.
03
Evidence Delivery
Deliver a reproducible validation report and rollout recommendation.
Built by operators across software engineering and clinical science.
Kolja Esders
Co-Founder
Former senior software engineer and tech lead at Google with deep distributed systems and product delivery experience.
Alexander Haas, MD
Co-Founder
Physician-scientist with oncology and clinical data science background across Harvard, Dana-Farber, and Heidelberg.
Answers to common qualification and deployment questions.
Do you support medical device companies?
Yes. The validation workflow is designed for both pharma and medical device teams, including software processes aligned with ISO 13485, 21 CFR Part 820, and IEC 62304.
Does Attestia replace human quality reviewers?
No. Attestia is built for human-supervised validation. It accelerates evidence generation while preserving accountable review and sign-off.
Can we run this without cloud-hosted models?
Yes. The platform is designed around controllable model deployment options, including local or private hosting strategies.
How is this different from generic copilots?
Generic copilots optimize convenience. Attestia focuses on validation evidence, risk thresholds, and audit-ready traceability for regulated workflows.
Start with one use case and get a decision-ready validation package.
Share your current workflow and blocker. We will scope a practical pilot for pharma or medical device qualification needs.
We respond directly to pilot requests and propose a scoped next step based on your submission.