Regulatory Intelligence for Medical Device Manufacturers

Your Device.
Your Market.
Your Compliance — Resolved.

Regulatory intelligence, compliance gap analysis, and clinical evidence documentation for medical device manufacturers in Asia entering US, EU, and UK markets. Class I through Class IIb non-implantable devices. FDA, EU MDR, and UK MDR. Built by a manufacturer — not an academic consultant.

Class I · Non-Active
Class IIa · Lower Risk Active
Class IIb · Active Devices
Excl. Implantables & Class III
Send Enquiry → View Device Scope ↓
Why Manufacturers Choose VerityNodes
  • 🏭
    Built by a Manufacturer
    25 years inside ISO 13485-certified regulated manufacturing — not consulting theory. We understand the gap between what regulators require and what documentation teams actually produce.
  • ⚡
    Full Classification Coverage
    Class I through Class IIb active devices. EU MDR, FDA, and UK MDR frameworks. IEC 60601 family standards for active devices. Covered together, not piecemeal.
  • 📡
    Three-Market Coverage
    FDA, EU MDR 2017/745, and UK MDR monitored continuously, filtered to your device classification and target market, delivered as monthly intelligence briefings.
  • 🇬🇧
    UK-Registered Entity
    VerityNodes Ltd, England & Wales. Professional indemnity insured. Senior regulatory intelligence from $1,500 — without the overhead of a full-time regulatory affairs director.
Currently accepting 3 new clients for Q2 2025 onboarding
EU MDR 2017/745
IEC 60601-1
IEC 60601-2-2 Electrosurgery
FDA 21 CFR Part 820
UK MDR 2002 as Amended
ISO 13485:2016
ISO 14971:2019
MEDDEV 2.7/1 Rev 4
IEC 62366-1 Usability
IEC 60601-1-2 EMC
Class I · IIa · IIb Active
UDI · EUDAMED
UKCA Marking
FDA 510(k) Pathway
EU MDR Annex XIV CER
MDCG Guidance Updates
EU MDR 2017/745
IEC 60601-1
IEC 60601-2-2 Electrosurgery
FDA 21 CFR Part 820
ISO 13485:2016
ISO 14971:2019
Who We Work With

Any Non-Implantable Medical Device
Targeting a Regulated Market

Class I through Class IIb non-implantable devices. FDA, EU MDR, UK MDR. Any Asian manufacturing base.

📋
Class I

Class I

  • QMS and technical file structure
  • Labelling and IFU compliance
  • EUDAMED and UDI readiness
🔬
Class IIa

Class IIa

  • Clinical evaluation — MEDDEV 2.7/1 Rev 4
  • Technical file and GSPR mapping
  • Post-market surveillance plan
⚡
Class IIb

Class IIb Active

  • IEC 60601-1 and EMC documentation
  • Usability engineering — IEC 62366-1
  • Class IIb clinical evidence — Art. 61
🌏
All Classes

All Classes · Three Markets

  • EU MDR 2017/745 — CE marking
  • FDA 510(k) — substantial equivalence
  • UK MDR — UKCA via MHRA
ℹ️

Scope boundaries: Our standard service covers Class I through Class IIb non-implantable medical devices. Class III devices, active implantables, and IVD (In Vitro Diagnostics) are outside our standard scope. IEC 62304 software lifecycle documentation review is also outside standard scope — where embedded software is present we identify and flag the requirement. We will always advise honestly during a discovery call if a device falls outside our scope, and can refer to appropriate specialists.

The Challenge

Why Regulatory Compliance
Stalls Market Entry

The same three gaps appear in nearly every manufacturer's documentation we review.

01

The Standards Scope Is Larger Than Expected

IEC 60601-1, EMC, usability engineering, and clinical evidence obligations all apply simultaneously. Most manufacturers discover the full scope mid-process — not before it.

IEC 60601-1 · IEC 62366-1 · EU MDR Annex I
02

EU MDR Clinical Evidence Is Not What It Was Under MDD

Article 61 and Annex XIV demand substantially more than the old MDD framework. Manufacturers who discover this at notified body stage face costly delays.

EU MDR Art. 61 · Annex XIV · MEDDEV 2.7/1 Rev 4
03

Requirements Change — Without Warning to Manufacturers

MDCG updates, IEC amendments, and FDA guidance revisions alter compliance requirements continuously. Without active monitoring, you learn about changes after they become problems.

MDCG 2020-1 · IEC 60601-1 · FDA Guidance
Our Services

Three Ways We Support
Your Regulatory Journey

One-time audit, monthly retainer, or clinical evidence documentation — each designed for a specific stage of your regulatory journey.

🔍
Entry Point

Regulatory Readiness Audit

  • ISO 13485 QMS and technical file review
  • Clinical evidence adequacy assessment
  • IEC 60601 check (active devices)
  • UDI, EUDAMED and PMS readiness
Class I Class IIa · Single market
$1,500
Class I Class IIa · Multi-market
$3,000
Class IIb Active · Single market
$2,500
Class IIb Active · Multi-market
$4,500
one-time · 10–15 business days Learn more →
📡
Core Service

Regulatory Intelligence Retainer

  • Monthly regulatory briefing report
  • IEC 60601 amendment tracking (active devices)
  • Gap identification memo — new vs current
  • Upcoming deadline alerts (EUDAMED, UDI)
  • Up to 4 advisory email questions/month
  • Quarterly 45-min strategy call
Class I IIa · per month
$2,500–$3,500
Class IIb Active · per month
$3,500–$5,500
monthly · rolling engagement Send enquiry →
📄
Project-Based

Clinical Evidence Documentation

  • Clinical Evaluation Plan (CEP)
  • State-of-the-art literature review
  • Clinical evidence gap analysis
  • CER sections — Annex XIV compliant
  • PMCF plan per Annex XIV Part B
  • Clinical white papers for investors
Class I Class IIa
$3,000–$6,000
Class IIb Active
$5,000–$10,000
per project · scope-dependent Discuss scope →
How It Works

From First Call to
Ongoing Intelligence

1

Discovery Call

30-minute, no-obligation conversation covering your device category, classification (Class I, IIa, or IIb active), target markets, and current documentation status.

2

Scope Assessment

We define exactly which regulatory frameworks and standards apply to your device — including applicable IEC 60601 particular standards for active devices — and identify the specific gaps to address.

3

Engagement Begins

Audit deliverable within 10–15 business days. Retainer clients receive their first monthly briefing within two weeks of onboarding, device-category filtered.

4

Ongoing Intelligence

Monthly briefings, gap alerts across regulatory and standards updates, and advisory access keep your compliance posture current as both regulations and IEC standards evolve.

Markets Served

Asia-Based Manufacturers
Entering Regulated Markets

Regulatory pathways from Asia into the three most demanding device markets in the world.

🇪🇺

Asia → European Union

CE marking via notified body. Technical file, clinical evaluation, EUDAMED, UDI, and PMS for Class I–IIb devices.

EU MDR Art. 61 Annex XIV CER EUDAMED UDI PMCF
🇺🇸

Asia → United States (FDA)

FDA 510(k) substantial equivalence. Predicate strategy, establishment registration, and device listing.

510(k) 21 CFR 820 Predicate Strategy FDA Registration
🇬🇧

Asia → United Kingdom

UKCA marking under UK MDR 2002. MHRA registration, UK Responsible Person, and CE-to-UKCA transition.

UKCA UK MDR 2002 MHRA UK Responsible Person
🌏

MedTech Startups — US, UK, EU

Regulatory strategy and submission preparation for early-stage companies without full-time regulatory affairs resource.

Pathway Strategy Classification Analysis Investor Docs Class I / IIa
The Founder

25 Years Inside Regulated Manufacturing — Before Regulatory Intelligence

I am not an academic consultant. I spent 25 years running ISO 13485-certified manufacturing for export to Europe and North America — managing technical files, notified body audits, and the gap between what regulators require and what manufacturers actually have prepared.

That background is the foundation of this service. I know what a technical file looks like from the inside, what a notified body auditor is looking for, and what a compliance gap costs when it surfaces at submission stage.

25
Years in regulated device manufacturing
I–IIb
Full active device scope coverage
3
Markets: FDA · EU MDR · UK MDR
Aqeel Abbas — Founder, VerityNodes Ltd
Aqeel Abbas
Founder, VerityNodes Ltd
Director, GERATI Medical
PHF — 25 Years Manufacturing
"I built this service because I know exactly what it costs a manufacturer to discover a documentation gap at notified body stage — and how avoidable it almost always is."
— Aqeel Abbas, Founder · VerityNodes Ltd
Free Resource

EU MDR 2017/745 Regulatory Readiness Checklist — Class I through Class IIb Devices

A structured self-assessment tool mapped to specific EU MDR articles, annexes, and MDCG guidance documents. Covers QMS, technical file, clinical evidence, labelling, risk management, PMS, UDI, and EUDAMED requirements. Use it to assess where your documentation stands before engaging a notified body — regardless of your device type.

No spam. One email with your checklist. Unsubscribe any time.

Get Started

Know Exactly Where Your Compliance Documentation Stands

Send us an enquiry. We will identify which regulatory frameworks and standards apply to your device, tell you honestly what the documentation gaps look like, and recommend the right starting point.

Send Enquiry → View Audit Service & Pricing

No obligation. No sales pressure. A direct conversation about your device and regulatory situation.