Easy13485 · Quality Statement
This manufacturer operates a Quality Management System built and maintained on the Easy13485 service — supported by IPP and structured for audit readiness. A statement of how quality work is organized, not a guarantee of product conformity.
What this statement means
The Easy13485 Quality Statement tells partners, investors and customers how this manufacturer runs quality work. It is a statement about structure and discipline — it does not transfer regulatory responsibility to IPP.
Built to the relevant standards
The Easy13485 structure is built around the standards auditors and notified bodies assess — addressed as processes, templates and roles. Scope depends on the manufacturer's product type and classification.
ISO 13485 (QMS), MDR 2017/745 documentation logic and ISO 14971 risk management — addressed as structured processes.
IEC 62304 and IEC 82304-1 embedded into development and traceability, with cybersecurity tasks integrated.
IEC 60601-1 and IEC 62366-1 supported via stage-gate checklists for verification deliverables.
Clinical evaluation aligned with MDR 2017/745 and MEDDEV 2.7/1, benefit–risk supported by experts.
Post-market surveillance, CAPA and complaint management, vigilance and recall logic.
IPP's role
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, with expert review as a quality gate. Certification, and the confirmation that the QMS is effectively operated, remain with the manufacturer and the responsible certification / notified body.
This statement reflects participation in the Easy13485 Quality Management Service. It does not constitute a CE marking, an ISO 13485 certificate, or a warranty of any specific medical device.
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Medical device manufacturers who commit to Easy13485 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.
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.
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.
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 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.
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