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Entry-Point ServiceOne-Time · Class I – IIb Active

Find Every Gap Before
Your Notified Body —
or the FDA — Does.

Comprehensive assessment of your medical device documentation against FDA, EU MDR, and UK MDR requirements — for any Class I through Class IIb non-implantable device, regardless of device type. Delivered as a prioritised gap report with regulatory citations, severity ratings, and a remediation roadmap.

Class I Non-Active Devices
Class IIa Medium Risk Devices
Class IIb Higher Risk Active
Excl. Implantables & Class III
Deliverable in 10–15 business days
From $1,500 (Class I/IIa) · $2,500 (Class IIb Active)
Commission Your Audit →See What's Covered ↓
Audit at a GlanceAvailable Now
Regulatory Readiness Audit
Engagement typeOne-time project
DeliverableGap Report + Roadmap
Markets coveredFDA · EU MDR · UK MDR
Device scopeClass I · IIa · IIb Active
Turnaround10–15 business days
Review call included✓ 45-min walkthrough
Pricing by class & market scope
Class IIIa · Single market
$1,500
Class IIIa · Multi-market
$3,000
Class IIb Active · Single
$2,500
Class IIb Active · Multi
$4,500
Commission Audit →

Response within one business day.

Why This Matters

Compliance Gaps Found Late Are Expensive. For Active Devices, Catastrophic.

A Regulatory Readiness Audit identifies these gaps on your schedule — not the notified body's.

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Notified Body Major Non-Conformity — Active Device
IEC 60601 gaps or missing Class IIb clinical evidence: 4–8 month remediation. Additional NB fees €8,000–€20,000. Sales pipeline impact: severe.
⚠️
FDA Deficiency Letter — Class IIb Active Device 510(k)
Missing performance data or incomplete predicate analysis for active devices adds 4–8 months minimum to review. Second submissions are common.
💡
VerityNodes Readiness Audit
Find the same gaps now — across your full documentation scope — at a fraction of the cost of discovering them at notified body or FDA review stage.
Audit Scope

Eight Areas. Every Device Class.
Every Target Market.

Each area reviewed against specific regulatory articles, annexes, and standards — including IEC 60601 family requirements for active devices. Active-specific areas clearly marked.

01/08All Classes
📋

Quality Management System

ISO 13485:2016 · FDA 21 CFR Part 820
02/08All Classes
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Technical File Structure

Completeness against EU MDR Annex II and III — device description, intended purpose, design information, and GSPR compliance mapping including active device-specific GSPR sections for electrical safety and EMC.

EU MDR Annex II · Annex III · GSPR Annex I §8–§17
03/08All Classes
⚖️

Risk Management File

Assessment against ISO 14971:2019 including hazard identification relevant to your device classification — electrical hazards, thermal risks, and EMI-related failure modes for active devices, and mechanical and biological hazards for non-active devices.

ISO 14971:2019 · EU MDR Annex I §8 · IEC 60601-1 §13
04/08All Classes
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Clinical Evidence Adequacy

Review against EU MDR Article 61 and Annex XIV. For Class IIb devices we assess whether the clinical evidence strategy addresses the higher evidentiary standard notified bodies apply at that classification level.

EU MDR Art. 61 · Annex XIV · MEDDEV 2.7/1 Rev 4
05/08Active Devices
⚡

IEC 60601 Standards Compliance

Assessment of IEC 60601-1 general requirements documentation alongside the applicable particular standard for your device type. We identify which particular standard applies, assess test evidence completeness, and flag compliance gaps against your technical file.

IEC 60601-1 · IEC 60601-1-2 EMC · IEC 60601-2-2 · IEC 60601-2-18
06/08Active Devices
🖐️

Usability Engineering

Review of your usability engineering file against IEC 62366-1. Active devices with user interfaces — control panels, touchscreens, alarm systems — require a complete usability engineering process that many manufacturers underestimate.

IEC 62366-1 · IEC 60601-1-6 · EU MDR Annex I §5
07/08All Classes
🏷️

Labelling, IFU & PMS

Assessment of labels and IFU against EU MDR Annex I Section 23, EN ISO 15223 symbols, and FDA labelling requirements. Also covers Post-Market Surveillance Plan completeness against EU MDR Articles 83–86.

EU MDR Annex I §23 · EN ISO 15223 · Art. 83–86
08/08All Classes
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UDI, EUDAMED & Registration

UDI assignment, labelling placement, and EUDAMED registration status. UDI carrier placement requirements vary by device classification and configuration — we assess compliance against the specific requirements that apply to your device.

EU MDR Art. 26–34 · EUDAMED · FDA UDI 21 CFR 830
ℹ️
Your Deliverable

A Gap Report That Tells You Exactly Where You Stand and What to Do Next

Within 10–15 business days: a structured gap report specific to your device, classification, and target market.

✓
Findings table — every gap with specific regulatory article, annex, or standard reference (IEC 60601 citations for active devices)
✓
Severity rating — Critical / High / Medium per finding so you know where to act first
✓
Active device section — IEC 60601, usability engineering, and EMC gaps presented separately for clarity
✓
Remediation roadmap — prioritised action plan with realistic effort estimates and sequencing guidance
✓
45-minute review call — walk through all findings, answer questions, agree next steps
✓
30-day follow-up window — one round of clarification questions at no additional cost
Sample Gap Report — ExtractCONFIDENTIAL
DeviceClass IIb Active Device · EU MDR + FDA · Multi-Market
Critical
No IEC 60601-1 test report — basic safety & essential performance not demonstrated
IEC 60601-1:2005+A1:2012 Cl.4 · EU MDR Annex I §8
Critical
IEC 60601-2-2 particular standard compliance not evidenced in technical file
IEC 60601-2-2:2017 · EU MDR Annex II §6.1
Critical
CER absent — no clinical evaluation for Class IIb active device
EU MDR Art. 61(1) · Annex XIV Part A
High
Usability engineering file missing — IEC 62366-1 process not initiated
IEC 62366-1:2015 · EU MDR Annex I §5
High
EMC test evidence absent — IEC 60601-1-2 undocumented
IEC 60601-1-2:2014+A1:2020
Medium
No standalone PMS plan — MDR requirement unmet
EU MDR Art. 84 · Annex III
Total findings
18
across 8 audit areas
Breakdown
5 Critical · 7 High · 6 Medium
How It Works

From Enquiry to Gap Report
in Four Steps

1
Day 1

Discovery Conversation

You complete a short form. We respond within one business day to schedule a 30-minute scoping call covering your device category, classification — including active device type — target markets, and documentation status.

30 min · free · no obligation
2
Day 2–3

Document Request

Secure transfer · NDA available
3
Day 4–15

Audit and Drafting

We review across all eight areas — active device areas assessed against IEC 60601 and IEC 62366-1 specifically. Findings mapped to regulatory references, severity-rated, and compiled into a structured gap report with remediation roadmap.

10–15 business days
4
Day 15–17

Walkthrough and Handover

45-minute call to review all findings together. Active device findings walked through separately so IEC standards implications are clearly understood. 30-day email follow-up window included.

45 min review call · included
Investment

Four Clear Tiers — No Hidden Fees

Priced by device classification and market scope. Fixed-price engagement confirmed before work begins. Class IIb active pricing reflects additional IEC 60601 standards review and more complex clinical evidence assessment.

Class IClass IIaSingle Market

Focused Audit

$1,500
fixed · one-time
  • All 8 audit areas
  • Single regulatory framework
  • Full gap report with citations
  • Severity-rated findings table
  • Prioritised remediation roadmap
  • 45-min review call
  • 30-day follow-up window
Commission →
Class IClass IIaMulti-Market

Full Readiness Audit

Class I or IIa devices targeting two or more markets — typically EU plus US or UK. Consolidated multi-market gap report with cross-framework comparison table.
$3,000
fixed · one-time
  • All 8 audit areas
  • Two or more regulatory frameworks
  • Cross-framework comparison
  • Severity-rated findings per market
  • Prioritised remediation roadmap
  • 45-min review call
  • 30-day follow-up window
Commission →
Class IIb ActiveSingle Market

Active Device Audit

Class IIb active devices targeting one primary market. Includes full IEC 60601-1 and applicable particular standard review, IEC 62366-1 usability engineering assessment, and EMC compliance check alongside all standard audit areas.
$2,500
fixed · one-time
  • All 8 audit areas
  • IEC 60601-1 + particular std. review
  • Usability engineering gap analysis
  • EMC compliance check
  • Active device clinical evidence review
  • 45-min review call
  • 30-day follow-up window
Commission →
Class IIb ActiveMulti-Market

Active Multi-Market Audit

Class IIb active devices targeting two or more markets — typically EU MDR plus FDA. The most comprehensive tier, covering all standards and all regulatory frameworks in one consolidated report with cross-framework comparison.
$4,500
fixed · one-time
  • All 8 audit areas
  • Full IEC 60601 family review
  • Two or more regulatory frameworks
  • Cross-framework comparison
  • FDA 510(k) readiness assessment
  • Active device clinical evidence
  • 45-min review call
  • 30-day follow-up window
Commission →
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At a Glance

What Each Tier Covers

Audit Area Class I/IIa · Single
$1,500		 Class I/IIa · Multi
$3,000		 Class IIb · Single
$2,500		 Class IIb · Multi
$4,500
ISO 13485 QMS✓ Full✓ Full✓ Full✓ Full
Technical File (Annex II/III)✓ Full✓ Full✓ Full✓ Full
Risk Management (ISO 14971)✓ Full✓ Full✓ Incl. electrical hazards✓ Incl. electrical hazards
Clinical Evidence (EU MDR Art.61)✓ Full✓ Full✓ Class IIb standard✓ Class IIb standard
IEC 60601-1 ComplianceNot applicableNot applicable✓ + particular std.IEC 60601-2-2 / -2-18✓ + particular std.IEC 60601-2-2 / -2-18
Usability Engineering (IEC 62366)Not applicableNot applicable✓ Full✓ Full
EMC Documentation (IEC 60601-1-2)Not applicableNot applicable✓ Full✓ Full
Labelling, IFU & PMS✓ Full✓ Full✓ Full✓ Full
UDI & EUDAMED✓ Full✓ Full✓ Full✓ Full
Markets covered1 market2+ markets1 market2+ markets
IEC 62304 Software LifecycleExcludedFlagged if applicableExcludedFlagged if applicableExcludedFlagged as discrete itemExcludedFlagged as discrete item
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Free Resource

Download a Sample Gap Report Extract

Download Sample →
Questions Answered

What Manufacturers Ask
Before Commissioning an Audit

IEC 62304:2006+A1:2015 · MDCG 2019-16
Commission Your Audit

Tell Us About Your Device and We Will Take It From There

Complete the form. We respond within one business day to confirm scope and schedule your free 30-minute scoping call.

  • Response within one business day — guaranteed
  • Scoping call free — no charge until engagement confirmed
  • Fixed-price engagement confirmed before work begins
  • NDA provided on request before documentation sharing
  • 25 years regulated device manufacturing — active and passive
  • UK-registered — VerityNodes Ltd, England & Wales
Commission Your Regulatory Readiness Audit
We respond within one business day

Response within one business day. No obligation to proceed.

VerityNodes Ltd · [email protected] · Registered in England and Wales.
Regulatory intelligence & drafting support — not regulated legal or regulatory affairs advice.

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