Ship documentation with confidence. Use guided, MDR/ISO-aligned templates and in-context help to build a clean, auditable file without the guesswork.
Built around MDR, ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 82304-1.
Responsibilities and approvals mapped to your team’s roles.
Guided inputs reduce omissions, inconsistencies, and rework.
Clean exports and traceability that stand up to scrutiny.
Design file, risk file, IFU, validation plan—mapped to MDR/ISO requirements.
Inline hints, examples, and references—reduce back-and-forth and rework.
Approvals and traceability built-in. Export audit-ready packages in one click.
Easy13485 combines the speed of an out-of-the-box solution with the flexibility to reflect each team’s specific setup.
Designed to develop high potentials—like top consulting firms—the Academy turns training into a strategic growth tool.
Consultants are used strategically, not permanently.
Answers in seconds, so teams stay in flow and budgets stay lean.
Confidence on audit day—fewer findings, fewer costly loops.
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.
