QMS Feature
Highlights
Highlights
Built for teams that need results, not paperwork.
Easy13485 combines pre-configured processes, clear ownership, and built-in training into a QMS that actually works in startup reality.
Your QMS. Compliant by Default.
Easy13485 is instantly ready, scalable, and aligned with ISO 13485 & MDR — so you can implement a working QMS in one day, not one year.
Ready-to-use processes
Audit-ready documentation
Training & records included
Fully Pre- Configured
No blank templates. All processes aligned with ISO 13485, MDR, ISO 14971, IEC 62304 and more. Define your scope and go live.
1-Day Implementation
Forget multi-month rollouts. With Easy13485, you import, assign roles, and launch your QMS in 24 hours.
Role-Based System
Built around predefined roles and responsibilities. Works with small or cross-functional startup teams.
Living System
Modular process building blocks your team actually uses – not just static PDFs or templates.
Academy - Integrated
Directly linked to learning paths. Each process has built-in training assignments to keep your team qualified and audit-ready.
Approved development at highest standards — audit-ready by design.
Easy13485 integrates ISO, MDR and IEC requirements into one practical Quality Management System: processes, templates, roles, and expert support — continuously maintained and structured for audits.
What you get
Everything you need to get audit-ready — without slowing down product work
Pre-audited ISO 13485 QMS templates
End-to-end process framework (PLC)
Roles & responsibilities built-in (PRRC/QMR support)
Training library + practical walkthroughs
Audit-ready evidence & report structure
Expert guidance as your quality gate
ISO & Regulatory Core
Your compliant foundation: QMS, MDR documentation, and risk management.
- ✓ ISO 13485 – Quality Management System
- ✓ MDR (EU 2017/745) – Medical Device File
- ✓ ISO 14971 – Risk Management
- ✓ Regulatory Requirements Subscription (updates)
Software & Digital Health
Software standards embedded into development and traceability.
- ✓ IEC 62304 – Medical device software lifecycle
- ✓ IEC 82304-1 – Health software
- ✓ Cybersecurity tasks integrated into the QMS
Product & Human Factors
Hardware, usability and verification steps guided via stage gates.
- ✓ IEC 60601-1 – Medical electrical equipment
- ✓ IEC 62366 – Usability engineering
- ✓ Stage-gate checklists for deliverables
Clinical Evaluation
Clinical evaluation aligned with MDR and established guidance.
- ✓ Clinical evaluation process (MDR 2017/745)
- ✓ MEDDEV 2.7/1 aligned approach
- ✓ Benefit–risk evaluation supported by experts
Post-Market & CAPA
After launch: PMS, vigilance, complaints, CAPA, recall strategy.
- ✓ Post-market surveillance (MDR)
- ✓ CAPA & Complaint Management
- ✓ Vigilance & Recall Management
ISO & Regulatory Core
Your compliant foundation: QMS, MDR documentation, and risk management.
- ISO 13485 – Quality Management System
- MDR (EU 2017/745) – Medical Device File
- ISO 14971 – Risk Management
- Regulatory Requirements Subscription (updates)
Software & Digital Health
Software standards embedded into development and traceability.
- IEC 62304 – Medical device software lifecycle
- IEC 82304-1 – Health software
- Cybersecurity tasks integrated into the QMS
Product & Human Factors
Hardware, usability and verification steps guided via stage gates.
- IEC 60601-1 – Medical electrical equipment
- IEC 62366 – Usability engineering
- Stage-gate checklists for deliverables
Clinical Evaluation
Clinical evaluation aligned with MDR and established guidance.
- Clinical evaluation process (MDR 2017/745)
- MEDDEV 2.7/1 aligned approach
- Benefit-risk evaluation supported by experts
Post-Market & CAPA
After launch: PMS, vigilance, complaints, CAPA, recall strategy.
- Post-market surveillance (MDR)
- CAPA & Complaint Management
- Vigilance & Recall Management
Declaration of Compliance to ISO 13485
IPP acts as regulatory consultant and confirms that medical device manufacturers committing to the Easy13485 Quality Management Service operate a complete and effective Quality Management System according to ISO 13485. The system is audited at installation and at regular intervals as required by relevant standards.
Not Sexy
But Safe
But Safe
Our QMS isn’t flashy – and that’s the point. It’s built to pass audits, not beauty contests. 100% structured, tested, and actually usable. Still better than drowning in spreadsheets.
The EASY13485 QMS-Service gives you a fully structured, startup-optimized quality management system that’s pre-configured, pre-filled and audit-ready – with no extra burden on your team.
You don’t need to customize endless templates or “translate” standards into your workflow. With EASY13485, you’re up and running in a day – not in 12 months.
Covered Standards by
Easy13485
Easy13485 is built as a layered compliance system.
Each layer unlocks speed now - and flexibility later.
1
QMS Core
Certification-ready foundation
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QMS Core
Certification-ready foundation
The core of EASY13485+ is a fully mapped ISO 13485 system, extended for EU and US regulatory expectations.
ISO 13485 · full
MDR 2017/745 · full
FDA 21 CFR 820 · full
This means: your QMS is audit-ready, traceable, and credible for investors from day one.
2
Global Market Access
Expand without rebuilding
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Global Market Access
Expand without rebuilding
EASY13485+ already maps the core requirements used by multiple international regulators.
MDSAP Core · full
Health Canada · full
TGA / ANVISA / PMDA · full
This means: entering new markets doesn’t require reworking your entire quality system.
3
Security & AI Governance
Future-proof compliance
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Security & AI Governance
Future-proof compliance
Beyond classic QMS, EASY13485+ integrates governance standards that are becoming mandatory for enterprise customers and AI-based products.
ISO 27001 · full
ISO 42001 · full
This means: fewer blockers in security reviews, AI assessments, and enterprise procurement.
In the Makerspace, these layers are translated into
weekly execution and real audit evidence.
Discover
The Makerspace
⚙️
QMS-Service
Easy13485 delivers out-of-the-box speed with the flexibility to match each team’s unique setup.
🎓
Academy
Built to develop high potentials, the Academy turns training into a strategic growth tool.
📄
Tech-Doc.
Consultants are used strategically, not permanently.
💻
Certificator.AI
Answers in seconds, so teams stay in flow and budgets stay lean.
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Audit Support
Confidence on audit day – fewer findings, fewer costly loops.
OR
Contact us
You Decide
Start smart. Choose how you want to begin.
For startups, we offer a simple entry into professional compliance and quality management.
E-Learning & free Consulting call
Build the right foundation and get rewarded.
- “16 Obligations of a Manufacturer” course
- Certificate after completion
- First consulting call included – free
Direct Consulting
Start immediately with tailored expert support.
- First consulting hour: €162
- No prerequisites
- Startup-focused, practical guidance
Office hours
Monday to Friday
8:00 am - 2:00 pm
8:00 am - 2:00 pm