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US FDA Medical Device Consulting

Branching into the US market can be a cumbersome task for medical device manufacturers, especially with increasing requirements on manufacturers to meet changes in regulations.

Advena can offer regulatory consultation to guide you through the process whether that be:

  • FDA Strategic Regulatory planning/classification
  • FDA 510(k)/PMS build/submission
  • Quality System Consulting (21 CFR Part 820)
  • FDA Pre-Submission meetings
  • Pre IDE meeting – Preparation/participation
  • Assistance with device listing/establishment registration

Specialising in assisting small to medium size companies , our dedicated experienced team will provide cost effective support to ensure an effective outcome.

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