Our Mission
PraxisVerify is building the secure, compliant bridge between life sciences companies and the certified human expertise they need. In an industry where AI can draft documents faster than ever, regulators still require human expert verification. We provide that critical link — faster, safer, and designed for regulatory inspection readiness.
The current process for engaging regulatory experts is broken. Companies spend months on vendor qualification, QMS onboarding, and contractual negotiations before a single document gets reviewed. PraxisVerify replaces this with one-time platform credentialing, reducing expert engagement from months to as little as 48 hours.
The Founder
Lisa Donlon is the Founder and Director of PraxisVerify. With over 20 years in life sciences — spanning clinical practice, notified body operations, and regulatory consulting — Lisa brings a rare combination of hands-on medical device experience and regulatory authority to the platform.
Lisa served as European Medical Devices Operations Manager at NSAI (National Standards Authority of Ireland), Ireland's EU Notified Body, where she was joint head of the Medical Devices department. In this role, she was the final decision maker on EU Annex IX and XI Certificates under the MDR and IVDR, personnel authoriser for conformity assessment, and achieved IVDR designation for the Notified Body during her tenure. Previously, as Certification and Inspection Officer at NSAI, she served as lead auditor for regulatory and non-regulatory medical device QMS assessments and product reviewer for MDD/MDR CE marking applications.
Before joining the notified body, Lisa spent 16 years as a clinical Vascular Physiologist in the HSE and Galway Clinic, where she established vascular study units, managed clinical risk assessments, and developed SOPs and quality systems — experience that grounds her regulatory work in real-world clinical practice.
Lisa holds an MSc in Pharmaceutical Technology & Regulatory Affairs (South East Technological University), a BSc (Hons) in Physiology (NUI Galway), and is an IRCA Medical Device Principal Auditor. She is also an Accredited Vascular Scientist (AVS) and holds certifications in the EU AI Act.
Through her consultancy, Donlon Life Science Consulting, and as Quality and Regulatory Lead and Person Responsible for Regulatory Compliance (PRRC) at Vertigenius (a digital health startup where she has achieved four consecutive Notified Body zero-finding audits at ISO 13485:2016 and EU MDR), Lisa saw first-hand how broken the expert engagement process was — and founded PraxisVerify to fix it.
What We Do
PraxisVerify is a secure marketplace connecting life sciences companies to pre-vetted regulatory experts. The platform provides:
- Zero-trust document review — experts review in-browser only. No downloads, no email, no risk. Automatic 90-day deletion.
- Pre-vetted experts — regulatory professionals with verified credentials in ISO 13485, 21 CFR Part 11, EU MDR, and FDA submissions.
- Complete audit trails — every action logged and traceable, designed to support 21 CFR Part 11 requirements.
- Rapid onboarding — one-time platform credentialing replaces per-client vendor qualification.
Who We Serve
PraxisVerify serves MedTech manufacturers, pharmaceutical companies, and medical device companies that need expert verification of regulatory documentation. Typical use cases include:
- FDA 510(k) submission review
- EU MDR Clinical Evaluation Report (CER) validation
- ISO 13485 gap analysis
- Pharma batch record review
- Design History File (DHF) verification
Based in Ireland
PraxisVerify Ltd is headquartered in Ireland, at the heart of Europe's life sciences hub. Ireland is home to 9 of the world's top 10 pharmaceutical companies (IDA Ireland) and a thriving MedTech sector, making it the ideal base for a platform serving the global regulatory compliance market.
Founded in 2025, PraxisVerify is currently in beta and actively onboarding MedTech manufacturers to shape the platform.