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Case Study 1
- High Volume Neoprene Medical Product
From prototype to production quantities
The Development Process
- Detailed drawing received from medical device manufacturer
- Aluminium moulds designed and sourced to produce required product
- Prototype products produced for initial customer testing
- Identification and trials of various neoprene compounds, to identify the most suitable material
- Further samples produced for clinical trials
Progression to Production to Levels
- Detailed product specification was agreed
- Manufacturing process was designed and documented
- Procedures designed to ensure traceability of the product
- Quality Audit was carried out by customer
- Early phase production commenced
- Progression to production levels of 10,000 units per week
- Product subject to in-process and final inspection
- Product packaged and dispatched with Certificate of Conformity
- Customer conducts Goods In sampling inspection to agreed AQL Level
Customer Service / Communication
- Partnership approach throughout development of product.
- Regular meetings and communication during weekly production
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