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The Founder · VerityNodes Ltd

Regulatory Intelligence
Built From the
Manufacturing Floor Up.

I spent four years studying medicine and twenty-five years manufacturing regulated medical devices — from Class I surgical instruments to Class IIb electrosurgical systems — for export to Western European and US markets. VerityNodes exists because I know exactly what the gap between regulatory requirement and manufacturing reality looks like from the inside.

Medical College — 4 years
ISO 13485 QMS — 25 years
Notified Body Audits
Technical File Development
Class I – IIb Devices
UK-Registered Entity
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Aqeel Abbas — Founder, VerityNodes Ltd
Aqeel Abbas
Founder, VerityNodes Ltd
Director, GERATI Medical
Quality & Regulatory Affairs Professional
Registered in England & Wales
25
Years regulated manufacturing
4
Years medical college
3
Markets: EU · US · UK

"The most expensive compliance gap is the one you discover at notified body stage. I built VerityNodes so manufacturers find it months earlier — when fixing it is a planned activity, not a crisis."

— Aqeel Abbas, Founder
The Background

From Medical School to the Manufacturing Floor to Regulatory Intelligence

I began with four years at medical college — a foundation in clinical sciences that shaped how I think about the devices I would later manufacture and the clinical evidence frameworks they must meet.

I moved into medical device manufacturing, and over 25 years built deep hands-on expertise in ISO 13485 quality management, technical file development, risk management under ISO 14971, and direct navigation of EU MDR, FDA, and UK MDR regulatory frameworks — not from a consultant's desk, but from inside manufacturing operations.

Our product range spanned the full spectrum: Class I and Class IIa reusable and single-use surgical instruments through to Class IIb electrosurgical and laparoscopic systems. We designed and exported laparoscopic surgical simulators to leading global brands in Western Europe and the United States — giving me direct experience of the documentation standards and notified body expectations of the most demanding regulated markets in the world.

Every device that left our facility required a complete technical file, clinical evaluation, risk management documentation, and ongoing post-market surveillance. I have sat across the table from notified body auditors. I know what they look for — and I know what manufacturers typically have wrong.

VerityNodes Ltd is the service I wished had existed when I was navigating those requirements. Expert regulatory intelligence, delivered at a price that mid-size manufacturers in Asia can actually afford.

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Early Career
Medical College
Four years of medical education — providing clinical context and understanding of the healthcare environment that shapes how medical devices are used, evaluated, and regulated.
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25 Years
Regulated Device Manufacturing
ISO 13485-certified manufacturing of Class I through Class IIb medical devices. Hands-on management of QMS, technical files, risk analysis, notified body audits, and regulatory submissions across EU MDR, FDA, and UK MDR frameworks.
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Specialist Focus
Technical File & Audit Expertise
Deep specialism in technical file development, compliance gap analysis, risk management documentation, and notified body audit preparation. Products exported to leading global brands in Western Europe and the United States.
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Current
GERATI Medical & VerityNodes Ltd
Director of GERATI Medical, a laparoscopic surgical trainer design and export business serving global brands. Founder of VerityNodes Ltd — UK-registered regulatory intelligence and clinical evidence documentation service for Asian manufacturers entering Western markets.
Core Expertise

Where 25 Years of Experience
Becomes Your Advantage

Every VerityNodes engagement draws on hands-on technical expertise built across two and a half decades of regulated device manufacturing.

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Technical File Development

EU MDR Annex II Annex III GSPR Mapping
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Risk Analysis & ISO 14971

Risk management file development and gap analysis against ISO 14971:2019 — including hazard identification, risk control measures, residual risk evaluation, and benefit-risk determination. Built from practical manufacturing experience, not textbook frameworks.

ISO 14971:2019 FMEA Benefit-Risk
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Compliance Gap Analysis

Systematic assessment of documentation against regulatory requirements — identifying gaps before they become notified body non-conformities or FDA deficiency letters. Delivered with specific article and clause references, severity ratings, and prioritised remediation roadmaps.

EU MDR FDA 21 CFR 820 ISO 13485
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Notified Body Navigation

Direct experience preparing for and managing notified body audits across EU MDR and MDD frameworks. Understanding of what assessors examine, how they interpret documentation, and how to present a technical file that supports a clean certification process.

NB Audit Prep MDR Transition Certification
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ISO 13485 Quality Systems

25 years operating within and managing ISO 13485-certified quality management systems — design controls, supplier qualification, CAPA, complaint handling, and management review. We audit QMS documentation from a practitioner's perspective, not an auditor's checklist.

ISO 13485:2016 CAPA Design Controls
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Clinical Evidence & CER Drafting

Clinical evaluation support per MEDDEV 2.7/1 Rev 4 and EU MDR Annex XIV — from clinical evaluation plans through literature analysis, equivalence assessment, and CER section drafting. Informed by medical college training and practical manufacturing experience with device performance data.

MEDDEV 2.7/1 Rev 4 Annex XIV PMCF Planning
Honest Positioning

What VerityNodes Is — and Is Not

Sophisticated clients appreciate transparency. Here is an honest statement of what this service covers and where its boundaries are.

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We are not a Notified Body

We do not certify devices, issue CE certificates, or act as a conformity assessment body. Our role is to ensure your documentation is in the best possible position before you engage one.

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We are not a regulatory law firm

We provide regulatory intelligence and documentation drafting support. We do not provide regulated legal advice. All regulatory submissions remain the manufacturer's responsibility.

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We are not a software validation specialist

IEC 62304 software lifecycle documentation review is outside our standard scope. Where embedded software is present we identify the requirement and recommend appropriate specialist review.

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We do not cover Class III or active implantable devices

Our standard scope covers Class I through Class IIb non-implantable devices. Class III and active implantables require specialist clinical expertise beyond our standard service scope. We will always say so honestly during any discovery call.

What we are: A regulatory intelligence and documentation drafting service built on 25 years of hands-on regulated manufacturing experience — delivering expert compliance support that makes genuine market entry achievable for mid-size manufacturers at a price point that reflects the reality of their business.

Work With Us

Book a Discovery Conversation

A free 30-minute call. We will discuss your device, your target market, and your current documentation position — and tell you honestly whether and how we can help.

Send Enquiry → View Regulatory Readiness Audit

No obligation. No sales pressure. A direct conversation.