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:
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.