Easy13485 Makerspace · Capability
A maintained Easy13485 workspace for QMS operation — roles, processes and documents, structured and ready to use. Aligned with ISO 13485 and the MDR, so you can go live with a working QMS in one day, not one year.
QMS feature highlights
Easy13485 combines pre-configured processes, clear ownership and built-in training into a QMS that actually works in startup reality.
No blank templates. All processes aligned with ISO 13485, MDR, ISO 14971, IEC 62304 and more. Define your scope and go live.
Forget multi-month rollouts. Import, assign roles and launch your QMS workspace in 24 hours.
Built around predefined roles and responsibilities. Works with small or cross-functional startup teams.
Modular process building blocks your team actually uses — not just static PDFs or templates.
Directly linked to learning paths. Each process has built-in training assignments to keep your team qualified and audit-ready.
What you get
Easy13485 integrates ISO, MDR and IEC requirements into one practical QMS: processes, templates, roles and expert support — continuously maintained and structured for audits. Everything you need to get audit-ready, without slowing down product work.
Covered standards
ISO, MDR and IEC requirements are built into the workspace as processes, templates and roles — scope depends on your product type and classification.
QMS, MDR documentation and risk management.
Software standards embedded into development and traceability.
Hardware, usability and verification steps guided via stage gates.
Clinical evaluation aligned with MDR and established guidance.
PMS, vigilance, complaints, CAPA and recall strategy.
Layered compliance system
Easy13485 is built as a layered system. In the Makerspace, these layers are translated into weekly execution and real audit evidence.
A fully mapped ISO 13485 system, extended for EU and US regulatory expectations.
ISO 13485 · mapped MDR 2017/745 · mapped FDA 21 CFR 820 · partial mapping
Your QMS is audit-ready, traceable and credible for investors from day one.
The workspace already maps core requirements used by multiple international regulators.
MDSAP core · mapped Health Canada · supported TGA / ANVISA / PMDA · supported
Entering new markets doesn't require reworking your entire quality system.
Governance standards that are becoming mandatory for enterprise customers and AI-based products.
ISO 27001 · supported ISO 42001 · supported
Fewer blockers in security reviews, AI assessments and enterprise procurement.
How IPP supports your ISO 13485 QMS
IPP acts as a regulatory consultant. The Easy13485 workspace provides a complete ISO 13485 process structure, set up for audit readiness and maintained over time. Certification, and the confirmation that your QMS is effectively operated, remain with your organization and the responsible certification / notified body.
Not sexy. But safe.
Our QMS isn't flashy — and that's the point. 100% structured, tested and actually usable. The Easy13485 QMS service is pre-configured, pre-filled and audit-ready, with no extra burden on your team. No endless template customizing, no "translating" standards into your workflow — you go live in a day, not in twelve months.
Easy13485 is instantly ready, scalable, and aligned with ISO 13485 & MDR — so you can implement a working QMS in one day, not one year.
Easy13485 combines pre-configured processes, clear ownership, and built-in training into a QMS that actually works in startup reality.
No blank templates. All processes aligned with ISO 13485, MDR, ISO 14971, IEC 62304 and more. Define your scope and go live.
Forget multi-month rollouts. With Easy13485, you import, assign roles, and launch your QMS in 24 hours.
Built around predefined roles and responsibilities. Works with small or cross-functional startup teams.
Modular process building blocks your team actually uses – not just static PDFs or templates.
Directly linked to learning paths. Each process has built-in training assignments to keep your team qualified and audit-ready.
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
Your compliant foundation: QMS, MDR documentation, and risk management.
Software standards embedded into development and traceability.
Hardware, usability and verification steps guided via stage gates.
Clinical evaluation aligned with MDR and established guidance.
After launch: PMS, vigilance, complaints, CAPA, recall strategy.
IPP acts as a 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.
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.
The core of Easy13485 is a fully mapped ISO 13485 system, extended for EU and US regulatory expectations.
This means: your QMS is audit-ready, traceable, and credible for investors from day one.
Easy13485 already maps the core requirements used by multiple international regulators.
This means: entering new markets doesn’t require reworking your entire quality system.
Beyond classic QMS, Easy13485 integrates governance standards that are becoming mandatory for enterprise customers and AI-based products.
This means: fewer blockers in security reviews, AI assessments, and enterprise procurement.
Claims, development and evidence — traceable from day one.
AI-supported access to Easy13485 roles, processes and templates.
Role-based training with documented competence.
A maintained QMS workspace for daily operation.
Checks, findings and audit-oriented preparation
You decide
A simple entry into professional compliance and quality management for startups — pick the path that fits where you are.
Build the right foundation: Manufacturer Obligations Assessment, certificate on completion, and a first consulting call included — free.
Start immediately with tailored expert support. First consulting, 120 € (45 min), no prerequisites — startup-focused, practical guidance.
Start smart. Choose how you want to begin.
For startups, we offer a simple entry into professional compliance and quality management.
Build the right foundation and get rewarded.
Start immediately with tailored expert support.
