Design and Development
It is quite often we find that manufacturers are woefully failing in maintaining design and development files. Following a structured design and development process early on in the development cycle and maintaining records is a critical process required to be followed by most regulatory agencies.
We at Alceon can provide you with the support to maintain your design and development files, even retrospectively using our subject-matter experts. Some of the areas where we can support you are:
- Conduct research to identify the inputs for the design of your product
- Make the verification and validation plans
- Identify test methods, develop protocols, and select labs to conduct design verification tests
- Design the validation protocols
- Compile the Design History File
We also have the capability to conduct Finite Element Analysis and have successfully done on orthopedic joints like total knee replacement and total hip replacement for submissions to the US FDA.
