cite cost and variable expertise as key challenges
would evaluate a compliant expert platform within 3 months
experience process burdens including QMS onboarding and contractual delays
Source: PraxisVerify market research of Life Science Decision Makers, 2025 (n=13)
The verification gap
Why Trust Can't Be Automated
AI can draft documents faster than ever. Regulators still require a qualified human expert to verify and sign off. A 510(k) needs a regulatory specialist's review. A Clinical Evaluation Report needs clinical-data appraisal. An ISO 13485 audit needs a qualified auditor.
97% of Irish manufacturing leaders in medtech, pharma and engineering plan to adopt AI (Ibec, 2026). The bottleneck shifts from drafting to verification.
Human verification is embedded in the regulatory frameworks:
FDA 510(k)
Predicate comparison, performance review, biocompatibility assessment by qualified specialists.
EU MDR CERs
Article 61 and MDCG 2020-13 require appraisal by evaluators with clinical and regulatory expertise.
ISO 13485 QMS
Clause 8.2.4: internal audits by trained auditors independent of the audited process.
21 CFR Part 11
Validated electronic record systems with complete audit trails.
None of these can be performed by AI alone. Each requires the right credentials, the right experience, and documented independence from the team that produced the work.
- Audit-ready
- Secure
- On-demand
What we're building
Four steps, forty-eight hours
A secure marketplace connecting life sciences companies to pre-vetted regulatory experts. Upload documents to a secure environment. Experts review in-browser — no downloads, no email, risk minimised.
-
01
Submit documents
Upload to a secure environment — no email, no downloads.
-
02
Matched in 48 hours
Pre-vetted expert with verified credentials in your domain.
-
03
Secure in-browser review
Review actions logged with timestamps. No local copies of documents.
-
04
Verified assessment
Expert sign-off and the review record. Documents deleted 90 days after the review is completed.*
Speed
Pre-vetted experts ready in 48 hours, not 3–6 months. One-time platform credentialing, available for any client engagement.
Security
Browser-based. No installation, no downloads, no email attachments. Automatic deletion 90 days after the review is completed.* Review actions logged with timestamps, supporting 21 CFR Part 11.
* Other copies connected with a submission, including those of withdrawn submissions, are being brought into the same schedule, except where the law requires us to keep them. Our DPIA, being completed before launch, will set out what is kept and for how long, and will be available to clients on request.
Compliance
Audit trails for 21 CFR Part 11 electronic records and signatures. Inspection-ready by design. ISO 13485 certification pending Q4 2026.
Human Verification
Pre-vetted experts review and sign off on FDA submissions, EU MDR CERs, ISO 13485 audits, and DHF verification. The verified-input layer regulators require.
Traditional approach vs PraxisVerify — the side-by-side
| Aspect | Traditional | PraxisVerify |
|---|---|---|
| Expert onboarding | 3–6 months per client | 48 hours (one-time credentialing) |
| Document security | Email attachments, downloads | Secure in-browser review |
| Audit trail | Manual logs, spreadsheets | Automated audit trail designed for 21 CFR Part 11 |
| Vendor qualification | Repeated per engagement | One-time platform credentialing |
| Document retention | Varies by provider | Automatic deletion 90 days after the review is completed* |
Transparency by design
Every action, time-stamped
Sample audit trail from a verified review. Each review action time-stamped and attributed.
Indicative sample. Real assignments produce equivalent records with the assigned expert and client identifiers.
-
2026-05-19 14:30:15 UTCDocument submitted for reviewHash: 0x4d8f…e2a1
-
2026-05-19 14:35:22 UTCExpert review initiatedHash: 0x9b1c…f3d4
-
2026-05-19 14:42:50 UTCVerified approval time-stampedHash: 0x2a7e…b5c6
-
2026-05-19 14:45:01 UTCSigned deliverable issuedHash: 0x8f12…a039
Common questions
What people ask first
What is PraxisVerify?
PraxisVerify is a secure marketplace that connects life sciences companies to pre-vetted regulatory experts for document verification. The platform replaces months of vendor qualification with one-time credentialing, reducing expert engagement timelines from 6 months to 48 hours.
How does PraxisVerify ensure document security?
Reviews take place in the browser only. No downloads are permitted, and uploaded documents are permanently deleted 90 days after the review is completed, not 90 days after upload, so long or slow projects do not trigger early deletion. We keep the record of each review (the summary report, the reviewer’s annotations and the expert’s training certificate) for our quality management system; other copies connected with a submission are being brought into the same schedule, and our DPIA, being completed before launch, will set out what is kept. Audit trails are designed to support 21 CFR Part 11 requirements, with review actions logged and traceable.
What compliance standards does PraxisVerify support?
PraxisVerify supports 21 CFR Part 11 audit trail requirements, with ISO 13485 certification pending in Q4 2026. The platform is designed for MedTech and Pharma regulatory workflows including FDA 510(k) submissions, EU MDR compliance, and quality management system documentation.
Who are PraxisVerify's experts?
PraxisVerify's experts are pre-vetted regulatory professionals with verified credentials in ISO 13485, 21 CFR Part 11, EU MDR, and FDA submission requirements. Each expert undergoes one-time platform credentialing and QMS training before being matched to verification assignments.
What is the High-Trust Bridge?
PraxisVerify is the High-Trust Bridge between life sciences companies and verified human expertise. AI can accelerate document drafting, but regulators still require qualified human experts to verify and sign off on submissions. PraxisVerify provides the pre-vetted experts who review and verify regulatory documentation across FDA, EU MDR, and ISO 13485 frameworks.
Early access
Two ways in. Pick your door.
We're onboarding our first wave of life sciences companies, and credentialing the experts who will review their work. Built in Ireland, founded on EU Notified Body experience. Founder bio and mission →
Regulatory experts
I review documents for a living
See the expert routeInvite only · one-time credentialing · no repeat vendor qualification