WuXi AppTec’s study designs for cleaning validations consider each device with a unique, customized approach.
Development of a medical device is a unique and custom process specific to each device. The preclinical device safety testing strategy must also be specific to the device and its indication.
Preclinical device safety testing, for a device designed for multiple uses, needs to validate the instructions for use (IFU). The validation design provides the device manufacturer evidence the instructions are comprehensive and reproducible.
To achieve these goals with a cleaning validation of a multi-use medical device, the study design must consider each device with a unique, customized approach.
We consider our customers the experts on their devices. We provide an extension of your expertise through our validation study design. We consider ourselves your partner through the process. We will leverage our understanding of the regulatory environment and our extensive product knowledge from conducting validations on more than 1500 products.
Our approach to validating instructions for clean begins with understanding your instructions and devising a strategy for the worst-case conditions. Considerations made with our approach to define worst-case scenarios include:
- Soil selection reflective of real world scenarios
- Creation of a challenge device
- We leverage our technical understanding of the methods to apply soils
- Product characteristics to establish master products of the device family
Our goal is to work in collaboration with you. This is not only to understand the device but also the pain points. We work to provide client access to our technical experts from the study design and quote process through final report signature and regulatory submission.
Learn more about our comprehensive, holistic approach to cleaning validations. Contact WuXi AppTec to arrange a meeting – email@example.com or 651-675-2000.