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Good People Working on Good Projects with Good Process

Case Study 2: Two Special 510(k)s

Situation Hospital supply company needed a non-sterile version of approved sterile devices, but lacked medical device experience.
Frestedt Approach
  • Set regulatory strategy
  • Worked with the company to update design records
  • Created essential labeling
  • Assisted with packaging changes and testing
  • Avoided costly technical changes to device
  • Performed risk analyses on changes made
  • Recommended strategies to complete development and launch ahead of schedule
Results Frestedt submitted special 510(k) to FDA ahead of deadline, and secured clearance (without questions) for highest priority products. Also, trained company’s newly hired regulatory staff and device design teams to meet regulatory requirements.

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