ISO 13485 — Practical worksheet

Practical learning

Trace a medical-device design change through risk review, supplier controls and complaints. Use the device family, change record and traceability evidence; training attendance is not product market authorization.

Learning outcomes: connect device requirements, risk controls, supplier control and complaint feedback within the quality system. Use a sample design change, component specification, supplier evidence and complaint trend. The exercise changes a material while leaving risk analysis and verification unchanged. Identify affected records and required approvals before implementation. Assessment evaluates the change trail and evidence of effectiveness; a supplier certificate alone cannot demonstrate conformity of the finished device or confer market authorisation.

Inputs for this worksheet

Use an anonymised, authorised example and identify the process, product or activity to which the exercise applies. Obtain the referenced edition or programme rules and record the applicable criterion before assessing a gap. Keep source records, assumptions and your proposed next action together. Do not submit confidential or personal records without permission; simulated inputs are suitable for this worksheet.

Check your evidence and its limits

Compare your answer with the stated evidence and failure case. A completed worksheet is a learning aid, not an audit report, an accredited assessment, a certification decision or product market authorisation. Kayra can discuss preparation support or a related training need. Any real decision requires the applicable rules, competent people and the responsible organisation or authority; this exercise creates no professional registration or certification powers.

Official references

• ISO — 13485