Acceptance of Terms
By accessing and using PraxisVerify (the “Platform”), you agree to these Terms of Service. If you do not agree, please do not use the Platform.
Platform Description
PraxisVerify is a secure marketplace connecting life sciences companies to pre-vetted regulatory experts for document review and verification. The Platform facilitates expert matching, secure document review, and audit trail generation.
The Platform is designed for life sciences document review workflows including FDA 510(k) submission verification, EU MDR Clinical Evaluation Report appraisal, ISO 13485 quality management system gap analysis, and Design History File review. All document review occurs within a secure, zero-trust browser environment with complete audit trails designed to support 21 CFR Part 11 requirements for electronic records.
Early Access
PraxisVerify is currently in early access. During this period, features, pricing, and availability may evolve as we refine the platform with our initial customers. We will provide reasonable notice of any material changes that affect your use of the Platform.
User Accounts
You are responsible for maintaining the security of your account credentials and for all activity under your account. You agree to provide accurate information and to notify us immediately of any unauthorised access.
Acceptable Use
You agree to use the Platform only for lawful purposes related to life sciences regulatory document review. You shall not:
- Upload malicious content
- Attempt to access other users’ data
- Reverse-engineer the Platform
- Use the Platform for any purpose unrelated to regulatory compliance
Intellectual Property
All documents uploaded to the Platform remain the intellectual property of the uploading party. PraxisVerify does not claim ownership of any client documents. Platform content, design, and technology are the property of PraxisVerify Ltd.
Expert reviewers may not copy, reproduce, distribute, or retain any client documents or data accessed through the Platform. Any work product generated during a review engagement (annotations, comments, assessment reports) becomes the property of the commissioning client upon completion. PraxisVerify retains no copies of client documents or expert work product beyond the 90-day retention period.
Confidentiality & Security
PraxisVerify operates a zero-trust security architecture for all document review activities. This means:
- In-browser review only — experts review documents within the platform’s secure environment. No downloads are permitted, and no documents are transmitted via email or external file-sharing services.
- Automatic 90-day deletion — all uploaded documents are permanently deleted 90 days after the review engagement closes, unless a longer retention period is agreed in writing or required by applicable regulation.
- Complete audit trails — every document access, review action, and status change is logged with timestamps and user attribution. These audit trails are designed to support 21 CFR Part 11 requirements for electronic records and electronic signatures.
- Expert credentialing — all experts undergo credential verification before gaining platform access. Credentials including ISO 13485 Lead Auditor qualifications, FDA regulatory affairs certifications, and EU MDR experience are verified against issuing bodies.
Documents uploaded to the Platform may contain commercially sensitive intellectual property, confidential clinical data, and proprietary manufacturing processes. Our security architecture reflects the sensitivity of this content and the regulatory standards governing its handling.
Limitation of Liability
PraxisVerify provides a platform for connecting companies with regulatory experts. The Platform does not provide regulatory advice. Expert opinions delivered through the Platform are those of the individual expert and do not constitute legal or regulatory counsel from PraxisVerify Ltd.
The Platform is a marketplace that facilitates connections between companies and independent regulatory experts. It does not replace the professional judgement of your own regulatory affairs team, nor does it constitute a formal regulatory submission review by any regulatory authority. All regulatory submissions remain the sole responsibility of the sponsoring organisation. Experts engaged through the Platform operate as independent professionals, not as agents or employees of PraxisVerify Ltd.
Governing Law
These terms are governed by the laws of Ireland. Any disputes shall be subject to the exclusive jurisdiction of the Irish courts.
PraxisVerify Ltd is registered in Ireland. For cross-border engagements, users acknowledge that the Platform may be used by companies and experts in multiple jurisdictions, including the EU, UK, USA, Canada, and Australia. Applicable regulatory requirements in each jurisdiction remain the responsibility of the respective parties.
Changes to Terms
We may update these terms from time to time. Changes will be posted on this page with a revised date. Continued use of the Platform constitutes acceptance of updated terms.
Contact
For questions about these terms, contact us at info@praxisverify.com.