Quality Warranty

QM System according to the Highest Regulatory Requirements

Medical device manufacturers who commit to Easy13458 Quality Management Service know how important it is to operate and maintain a QMS that meets the strictest standards.

Medical device manufacturers using the Easy13485 Quality Management Service for medical devices, implement and document all requirements for medical devices in a binding and verifiable manner. This way they assure that all activities are performed with the highest quality standards and that your products meet the regulatory requirements.

Your Benefit as End Customer and User of the Medical Device

What does this mean for you as a customer? You can rely on Easy13485 to ensure that your device meet all the requirements of the Medical Device Regulation (MDR). Whether it is risk management, software development, IT security or usability – we cover all relevant areas and ensure that the QMS is fully compliant with the applicable standards such as ISO 13485, ISO 14971, IEC 62304, IEC 82304-1, EN 60601-1 and IEC 62366.

Maximum Safety for the Manufacturer and the Medical Device

Our service offers you the security that the manufactured medical devices meet the highest quality standards and that you stand out positively on the market.
Easy13485 supports you in efficiently designing the QMS while always keeping an eye on the requirements.
We are your reliable partner for successful certification and ensure that your company masters the compliance requirements without any problems.

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.

Discover - The Makerspace

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QMS-Service

Easy13485 combines the speed of an out-of-the-box solution with the flexibility to reflect each team’s specific setup.

🎓
Academy

Designed to develop high potentials—like top consulting firms—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

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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

you ARe a medical device manufacturer?

Join our growing customer base today and convince yourself of the advantages Easy13485 offers you. Rely on our expertise and optimize your QMS for sustainable success!
Contact us now to learn more about Easy13485 and how we can help you to push your QM System to the next level. Your success is our mission.

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