ISO 13485:2016 Manufacturing
During the production-tooling phase, Movement will provide ongoing liaison to the client and the sub-contractors chosen, answering any technical queries that will arise.
The tool design and production phase is the most important and it is crucial that it is produced by world class suppliers and managed by expert professionals. Cutting steel will only commence once the tooling design is signed off by Movement.
Movement will review all first production samples with the client when they become available, testing the quality and performance of each part against the production specification.
If a component needs to be modified, Movement will revise the 3D model and 2D drawing and re-issue it to the subcontractor concerned.
With most parts, and particularly in the case of moulded plastic parts and metal extrusions, it is normal to expect minor ‘tweaking’ of parts before full production, as some features cannot be accurately tested until a production sample becomes available.
During this phase, Movement will at all times maintain a fully updated production CAD database and BOM, so that any revisions to parts will be recorded and the revision history will be documented and therefore fully traceable.
Movement is partnered with an ISO 13485:2016 certified manufacturer in Shanghai, China to provide our clients with the full turnkey development and manufacturing solution for medical devices. Manufacturing includes;
Plastic Injection Mould/Tooling & Plastic Blow Mould/Tooling
Cleanroom Plastic Part Injection Moulding and Blow Moulding ISO 13485:2016
Cleanroom Assembly ISO 13485:2016 & White Room Assembly
Thermoform Medical Product Packaging, e.g. PVC, PET & PETG