Source: PraxisVerify market research of Life Science Decision Makers, 2025 (n=13)
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.
The Regulatory Verification Gap
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. Today, getting that expert in front of the document takes 3–6 months of vendor qualification, QMS onboarding, and contracts. PraxisVerify makes that bridge:
- Audit-Ready
- Secure
- On-Demand
What We're Building
A secure marketplace connecting life sciences companies to pre-vetted regulatory experts. Upload documents to a zero-trust environment. Experts review in-browser — no downloads, no email, risk minimised.
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1Submit documents
Upload to a zero-trust environment — no email, no downloads.
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2Matched in 48 hours
Pre-vetted expert with verified credentials in your domain.
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3Secure in-browser review
Every access event logged with timestamps. No local copies.
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4Verified assessment
Expert sign-off plus complete audit trail. Auto-deleted at 90 days.
| Aspect | Traditional Approach | PraxisVerify |
|---|---|---|
| Expert Onboarding | 3–6 months per client | 48 hours (one-time credentialing) |
| Document Security | Email attachments, downloads | Zero-trust 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 90-day deletion |
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Speed
Pre-vetted experts ready in 48 hours, not 3–6 months. One-time platform credentialing, available for any client engagement.
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Security Audit Ready
Browser-based, zero-trust. No installation, no downloads, no email attachments. Automatic 90-day deletion. Every action logged with timestamps, supporting 21 CFR Part 11.
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Compliance
Audit trails for 21 CFR Part 11 electronic records and signatures. Inspection-ready by design. ISO 13485 certification in progress.
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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.
Transparency by Design
Sample audit trail from a verified review. Every action time-stamped, every change signed.
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2026-05-19 14:30:15 UTCDocument submitted for reviewHash: 0x4d8f…e2a1
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2026-05-19 14:35:22 UTCExpert review initiatedHash: 0x9b1c…f3d4
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2026-05-19 14:42:50 UTCVerified approval time-stampedHash: 0x2a7e…b5c6
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2026-05-19 14:45:01 UTCSigned deliverable issuedHash: 0x8f12…a039
Indicative sample. Real assignments produce equivalent records with the assigned expert and client identifiers.
About PraxisVerify
Built in Ireland, founded on EU Notified Body experience.
For MedTech Manufacturers — Early Access
We're onboarding our first wave of life sciences sponsors. Where do you stand? (Applying as a regulatory expert? Head to our experts page — that route is separate.)