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Everything around the test report.

Gap analysis, submission files and scheme certification — one team, from scoping to market.

ISO 13485 · MDR · CRA · PCI — one evidence set, four markets
GMA · Global Market Access · Compliance Automation

The GMA Platform

One workspace for you, our reviewers and the Notified Body — clause mapping, e-signatures, report generation and audit trails, weeks off the cycle.

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LIVECompliance Portal

Acme MedTech — ISO 13485 Certification Project

212 clauses · 17 modules · IEC 81001-5-1 mapped · next internal audit 2027-03-15
+ Generate Part 11 report
Clauses approved
189 /212
89% · 14 under review
Evidence items
522
ISO 13485 212 + PCI DSS 310
Part 11 signatures
167 /189
Immutable audit trail · 0 exceptions
Recently generated · AUTO
ISO
ISO 13485 Internal Audit Report
212 clauses · 17 modules · IEC 81001-5-1 mapped
05-18SIGNEDDownload ↓
PCI
PCI DSS v4.0 RoC (Report on Compliance)
310 items · 12 chapters · QSA approved
05-16SIGNINGReview →
FDA
FDA 21 CFR Part 11 Audit Trail Report
Complete e-record & signature history
05-15READYDownload ↓
DoC
EU Declaration of Conformity
CRA Annex I · prEN 40000 mapped
05-14SIGNINGReview →
CoC
Certificate of Conformity
EN 18031-1:2024 · Two-party e-signature
05-12READYDownload ↓
NB
Notified Body Submission Package
NB 3121 · full submission set
05-10QUEUEDReview →
Latest thread · @mention auto-notifies · LIVE
A
Acme MedTech · ClientCLIENT· 12 min ago

@reviewer.lead Clause 7.5.2 supplier evaluation records and the IEC 81001-5-1 SBOM are uploaded. Please review evidence revision 3.

R
Reviewer Lead · SVS LabLAB· 6 min ago · SIGNED

Rev 3 is approved against clause 7.5.2 with a 21 CFR Part 11 e-signature and is now permanently sealed. Any future change creates a new revision with a full audit trail.

Illustrative project view — example data.
01

Online Assessment & Gap Analysis

Mapped precisely to EU CRA, EN 18031 and Common Criteria requirements.

02

Centralized Evidence & Version Control

A single source of truth with full audit trails, two-way access rights and automatic versioning.

03

One-Click Compliance Deliverables

DoC, CoC and NB-review documents generated across MDR, FDA, CRA and PCI frameworks.

04

Lab, Reviewers & Notified Body — Connected

Built-in reviewer communication with cloud submission, progress tracking and live Q&A.

Next step

Not sure where to start? Join a training session.

Free courses on EU CRA, MDR and ISO 13485, taught by Applus+ Laboratories Notified Body reviewers who read real submissions every week — the fastest way to brief your team before an engagement.