Do you design, order, or have responsibility for quality assurance functions (inspections) for critical characteristics of disposable medical devices?
Quality actually starts when the first concept of the product idea is postulated by the design engineering team. The manufacturing of medical devices (made of medical foam or tape) is much different than manufacturing “rigid” items such as plastic components for a car. This is because most medical materials have an elongation factor, so accurate and precise measurements usually demonstrate more variability.
The article entitled “Process Capability/Medical Devices” strives to help you understand the common pitfalls in the main aspects of disposable medical device manufacturing (converting) from:
- The physical properties in the selection of materials
- Process inspection/controls
- The expression of critical characteristics into Cpk terms (capability)
- Accurately estimating your possible production failures and expressing this figure in defects per million.
Click here to learn more about Process Capability for disposable medical devices.