The quality expectations and documentation needs in the medical device industry is demanding. As engineering needs vary, having a trusted resource can make or break a new product introduction. Doing the technical work alone is not enough.
Can the medical device consultant understand and document the risks involved? Understanding is vital for the Failure Modes and Effects Analysis activities that are an ongoing part of an organization. Alignment of the risk management process is essential for balanced management. Can they document the equipment to make for an easy Installation Qualification (IQ)? Strength in this area makes the transition and scaling in manufacturing much more straightforward. It also sets up the baseline for the equipment set up. Can the medical device consultant explore the process window and challenge the extreme values to justify the final product settings? Well done, Operational Qualification (OQ) will accelerate the eventual final process documentation. OQ also provides confidence for the Process Qualification (PQ), and knowledge to expedite any future root cause analysis. Can the medical device consultant execute during the PQ and achieve a strong process capability? Failure at this stage can delay clinical studies and the eventual submission to the FDA. Limited capacity leads to reduced production yields, costing the organization in the long term as well.
If the automation project includes test method development, this also needs validating. This area has similar requirements and documentation. Because design validation uses test methods, it is essential to do it early and establish it for all future users.
Understanding the FDA expectations allows the medical device consultant to execute the project and provide the documentation with the timing required to leverage the work at the proper time. It is much easier for an organization to go to one source who can automate a manufacturing process and the test method, while also providing FDA ready support documentation. Hiring one medical device consultant organization to provide all of these skills together is a value that makes your project execution confident.
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