Case Study Details

Case Study Information

Project Name: SaMD FDA Submission

Service: Regulatory Submission & Go To Market Support

Client: Private

  • Complete Date: 2019

Performed key cybersecurity activities in preparation for a US FDA submission, for a machine learning based Software as a Medical Device solution being developed by a startup Medtech company.

This project was required to support the regulatory submission and approval of a software as a medical device solution, as US FDA requires various cybersecurity activities during a submission.

SaMD FDA Submission

The project involved the following:
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