- Competitive Analysis
- Specification
- Design Control
- Electronics Software And Hardware Design
- Industrial Design
- Proof Of Principle Rigs
- Prototyping
- Pre-Production
- Approvals Liaison And Management
- Production
- Product Lifecycle
The development process for medical electronic devices follows a tightly controlled procedure. There are several key stages to ensure the design complies to the highest medical standards appropriate to the product.
Risk analysis - Working with our customer a detailed analysis is carried out before any design is started. This helps to identify the likely risks associated with the product being developed. Throughout the product design and development cycle this risk analysis is revised and updated and the process will be continued by the client for the life of the product.
FMEA analysis - Triteq’s FMEA analysis of a design is used to identify the effects and the causes for all potential failure modes. The probability of an occurrence, an assessment of severity and methods of detecting a failure can then be made. Based upon this information the risks can be prioritised and actions taken to respond and mitigate these failures.
Verification - Verification of the design is carried out to a test plan on fully functional preproduction units. This ensures compliance with the product specification, the application and international standards for medical products.
Validation - Triteq Medical will provide the appropriate documentation for approval of the device and can oversee and manage the statutory validation procedure.