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
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.
