Assembling a medical device under ISO13485

Assembling a Medical Device under ISO13485

Project Overview

For one of our clients, we built a medical device under ISO13485. Our services included handling all incoming and outgoing components, storing them in our warehouse, performing quality checks, and labeling the parts with batch codes for complete traceability.

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Process

1. Receiving Components: The client orders parts from their suppliers, which are delivered to our warehouse.

2. Quality Checks: We book receipt of the parts, perform quality checks, and label the parts with batch codes.

3. Assembly: The client sends a production order specifying the number of devices to be built. We pick the parts, book them on the production order, and generate a unique identifier for each device. During each work step, parts used are scanned with their batch codes.

4. Testing and Packaging: After assembly, each device is extensively tested, labeled, and registered in the central system. Devices are packed with instruction manuals and prepared for transportation.

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Collaboration

Our engineers maintain close contact with the developers of the device to optimize the assembly process and create detailed working instructions.