Product realization

Design and development

Planning, inputs, outputs, review, verification, validation and change control for the design, with the design file as central evidence.

Purchasing and critical suppliers

Evaluation and selection of suppliers based on their impact on the product, with verification of purchased items before use.

Production, traceability and UDI

Controlled production conditions, unique device identification (UDI) and batch traceability from raw material to the patient.

What an auditor usually asks for

• A design and development file with verification and validation
• Documented evaluation criteria for critical suppliers
• Batch and UDI traceability through to point of use
• Product risk management under ISO 14971

How to cover product realization in Kimobox

1. 1Manage the design file with controlled versions, review and approval.
2. 2Onboard and evaluate critical suppliers from the supplier portal.
3. 3Log batch and UDI traceability from raw material through to delivery.

Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

1. ISO 13485:2016 — Medical devices. Quality management systems ISO · March 2016
2. Regulation (EU) 2017/745 on medical devices EUR-Lex · 5 April 2017
3. ISO 14971:2019 — Application of risk management to medical devices ISO · 2019 ed.