Easy13485 Makerspace · Capability
Technical documentation isn't created at the end. With Easy13485 it is built step by step along your Product Life Cycle — fully aligned with ISO 13485 and the MDR from day one.
Along the PLC
Clear activities and defined outputs for every phase — your evidence grows with the product, not after it.
Non-active medical devices, Software as a Medical Device (SaMD), medical electrical systems and custom-made products.
Clear activities and defined outputs for each PLC phase — no guessing what comes next, no missing steps.
50+ audit-tested templates aligned with MDR Annex II & III and ISO 13485 development logic.
Records, approvals and traceability stay consistent across QMS processes and development activities.
Software, electronics, mechanics, usability, clinical evaluation and risk management — integrated when needed.
The outcome
One connected system instead of documents retrofitted before an audit.
All required development steps and documentation outputs are covered across the full life cycle.
Aligned terminology, logic and traceability across all documents.
Evidence exists continuously and can be reviewed at any point — not just before certification.
Regulatory frameworks covered
Aligned to the PLC and connected to your QMS. Scope depends on product type and classification — the framework helps you apply the right requirements without building everything from scratch.
DIN EN ISO 13485:2021 — Medical devices QMS
EN ISO 14971:2019 + A11:2021 — Risk management
MDR Annex II & III — Technical documentation structure
MDR Chapter II (Article 10) — Manufacturer obligations
IEC 62366-1:2015 + A1:2020 — Usability engineering
Clinical evaluation (MDR Annex XIV) — evidence and documentation logic (module)
IEC 62304:2006 + A1:2015 — Software lifecycle processes
IEC 82304-1:2017 — Health software
IEC 81001-5-1:2022 — Health software security
Next step
Stop retrofitting documents. Use a product-lifecycle-driven workflow that produces audit-ready evidence continuously — aligned with ISO 13485 and MDR Annex II and III.
Easy13485 Makerspace · Capability
Technical documentation isn't created at the end. With Easy13485 it is built step by step along your Product Life Cycle — fully aligned with ISO 13485 and the MDR from day one.
Technical documentation isn’t created at the end.
With Easy13485, it is built step by step along your Product Life Cycle — fully aligned with ISO 13485 and the MDR from day one.
Non-active medical devices, Software as a Medical Device (SaMD), medical electrical systems, and custom-made products.
Clear activities and defined outputs for each PLC phase — no guessing what comes next, no missing steps.
50+ audit-tested templates aligned with MDR Annex II & III and ISO 13485 development logic.
Records, approvals, and traceability remain consistent across QMS processes and development activities.
Software, electronics, mechanics, usability, clinical evaluation, and risk management — seamlessly integrated.
Easy13485 guides you through every phase of product development — from defining the intended use to signing the Declaration of Conformity. Technical documentation is created as a natural outcome of development work, not as a separate task at the end.
All required development steps and documentation outputs
are covered across the full life cycle.
One connected system — aligned terminology, logic,
and traceability across all documents.
Evidence exists continuously and can be reviewed
at any point — not just before certification.
Easy13485 structures your technical documentation around the standards and MDR requirements that auditors and notified bodies actually assess — aligned to the PLC and connected to your QMS.
Scope depends on product type and classification (e.g., software, electrical systems, custom-made). The framework helps you apply the right requirements without building everything from scratch.
Stop retrofitting documents. Use a product lifecycle – driven workflow that produces
audit-ready evidence continuously – aligned with ISO 13485 and MDR Annex II and III.
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
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