After concluding the project, the company has achieved
a clear understanding of the FDA requirements for the
Pre-market submission and they get the Pre-market
submission approval.
About this Case Study
The case study involved verifying GMP compliance in an IVD company to enable the commercialisation of their products in the USA.
A mock inspection was conducted based on 21 CFR 820 requirements, customized to the company’s IVD products and processes.
To learn more about the successful project and the comprehensive results achieved in verifying GMP compliance for the IVD company, download the full case study now.
Discover the step-by-step process, key improvements, and valuable insights that led to FDA pre-market submission approval
Download the Case Study
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