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, Quality Management System (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.
This is happening in a market where skills scarcity is already acute: Skillnet Ireland's Talent Landscape 2025 found that 58% of businesses report difficulty sourcing skills, and 59% expect their core skill requirements to evolve within the next three years.
The challenge is compounded by the regulatory environment itself. The EU MDR transition — which moved the medical device regulatory framework from the Medical Devices Directive (MDD) to the Medical Devices Regulation (EU 2017/745) — has fundamentally increased the documentation burden on manufacturers. Clinical Evaluation Reports, Post-Market Clinical Follow-up plans, Periodic Safety Update Reports, and Summary of Safety and Clinical Performance documents are now mandatory for a wider range of devices. These are lifecycle obligations — they don't end at certification. Every device on the market requires ongoing post-market surveillance, periodic clinical data updates, and vigilance reporting for as long as it remains available.
For companies navigating this landscape, access to qualified regulatory expertise is not a convenience — it's a prerequisite for market access and ongoing compliance. PraxisVerify exists to make that access faster, safer, and auditable.
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.
Watch: Leveraging AI in Medical Device Quality & Regulatory Workflows (Leap Compliance)
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, risk minimised. 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.
The FDA received approximately 3,500 510(k) submissions in fiscal year 2024 (FDA CDRH Annual Report). Each submission requires independent verification of predicate device comparisons, performance data, and biocompatibility assessments — the exact workflow PraxisVerify is built to streamline.
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
Our clients range from early-stage MedTech startups preparing their first CE marking application to established manufacturers managing post-market obligations across multiple jurisdictions. Whether a company is bringing a Class IIa device through the EU MDR pathway, preparing a De Novo classification request for the FDA, conducting a pre-submission gap analysis against ISO 13485:2016, or managing vigilance reporting and post-market surveillance across multiple product lines, the common thread is the same: they need qualified, independent expert review without the months of onboarding overhead that traditional consulting relationships require.
We also serve the experts themselves. Regulatory professionals with ISO 13485 Lead Auditor credentials, FDA regulatory affairs experience, EU Notified Body backgrounds, or specialisations in SaMD, AI/ML regulatory requirements, or biostatistics can join the PraxisVerify network through a one-time credentialing process, gaining access to verification assignments without the repetitive vendor qualification requirements that consume significant unbillable time.
Book a 20-min DemoBased in Ireland
PraxisVerify Limited 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 ranks as the second-largest exporter of medical devices in Europe (Ibec, 2026). Irish manufacturing in medtech, pharma and engineering added over 20,000 direct jobs in 2024, employing more than 240,000 people in total (Ibec, 2026). That scale — combined with deep regulatory expertise built around Europe's Notified Body infrastructure — makes Ireland the ideal base for a platform serving the global regulatory compliance market across Ireland, the UK, the US, Canada and Australia.
Founded in 2025, PraxisVerify is actively onboarding MedTech manufacturers through its early access programme.