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Case Study 2
- High Volume Natural Rubber Latex Medical Product
From prototype to production quantities
The Development Process
- Detailed drawing received from medical device manufacturer
- Moulds designed to produce the product
- SLA protoype master created from CAD data
- Prototype castings arranged from SLA master
- Prototype products produced for initial customer testing and approval
- Clinical trials were held
Progression to Production to Levels
- Detailed product specification was agreed
- Manufacturing process was designed and documented in detail
- Batch records were designed, in consultation with the customer, to keep detailed records of each stage of the process
- Batch Release reports were designed to include agreed criteria for final inspection
- Production moulds purchased
- Early phase production commenced
- Progression to production levels of 20,000 units per week
- Product subject to in-process and final inspection
- Product packaged and dispatched with Certificate of Conformity
Customer Service / Communication
- Partnership approach throughout development of product
- Regular meetings and communication during weekly production
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Medical