During the Engineering Phase the 3-D design will be detailed to prepare engineering documents in accordance with ISO standard 13485 including:
- The technical design with drawings and calculations
- The risk analysis & traceability
- The Design History File
- The assembly diagram & test instructions
- Summary of the tooling and product costs
Validated 0 series
De Koningh Medical Systems will use the engineering documents to develop and test a number of prototypes. On the completion of the Test Phase the engineering documents will be amended as required to specify the definitive design, and the 0 series will be validated for production, sterilisation and use.