Book a Demo
See the platform in action. Book a free 20-minute walkthrough and we'll show you how PraxisVerify reduces expert engagement from months to hours. During the demo, we'll walk through the secure document review workflow, show you how expert matching works, and explain how the audit trail meets 21 CFR Part 11 requirements.
Whether you're preparing for an FDA submission, need a Clinical Evaluation Report reviewed, or want to see how platform credentialing replaces vendor qualification, the demo is tailored to your use case.
Book a 20-min DemoGet in Touch
We welcome enquiries from MedTech manufacturers, pharmaceutical companies, and regulatory professionals. Whether you have a question about the platform, want to discuss a specific compliance challenge, or are interested in partnership opportunities, we'd love to hear from you.
We aim to respond within one business day. For urgent matters, please include "Urgent" in your subject line.
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Common Use Cases
Companies typically reach out when they need expert support for:
- FDA 510(k) submission review — pre-submission technical documentation verification by a regulatory specialist with FDA experience.
- EU MDR Clinical Evaluation Report (CER) review — clinical data appraisal and literature review validation by an experienced assessor.
- ISO 13485 gap analysis — third-party QMS assessment by a qualified lead auditor ahead of certification or surveillance audits.
- Design History File (DHF) verification — independent review of design inputs, outputs, verification, and validation records.
- Post-market surveillance — vigilance report assessment and PMCF strategy validation for ongoing EU MDR compliance.
Not sure which service fits your needs? Book a demo and we'll help you scope the engagement.
Interested in Joining as an Expert?
PraxisVerify is actively building its network of pre-vetted regulatory experts. We're looking for quality and regulatory professionals with credentials in:
- ISO 13485 Lead Auditor or internal auditor qualifications
- EU MDR / IVDR regulatory affairs experience
- FDA 510(k), PMA, or De Novo submission experience
- 21 CFR Part 11 compliance and computer systems validation
- Clinical evaluation and post-market surveillance
- MDSAP audit experience
The platform handles all vendor qualification paperwork centrally, so you credential once and can accept review assignments from multiple companies without repeating onboarding. Experts set their own availability and review rates.
Email info@praxisverify.com with the subject line "Expert Interest" and we'll send you the details.
Location
PraxisVerify Ltd
Ireland
At the heart of Europe's life sciences hub — home to 9 of the world's top 10 pharmaceutical companies and a thriving MedTech sector. Ireland's strong regulatory ecosystem, combined with its position as a European base for medical device manufacturers and contract research organisations, makes it the ideal home for a platform serving global life sciences compliance.
