Get through 510(k) approval and FDA inspection without any problems

What we can do for you

Many people thing FDA reviews are strict and formal. Violating the requirements of the US authorities can have wide ramifications. We help you in tasks such as:

  • Checking your documents e.g. before you hand them in.
  • Create missing documents.
  • Formulate or view letters to the FDA.
  • "Register" and "list" your products or organization at the FDA.
  • Review your QM system for conformity with the requirements of 21 CFR part 820 (QSR).
  • Create your "QSR-compliant" QM system.

This makes you fully prepared for a 510(k) filing and an FDA inspection.

 

How we can help you

Depending on your task, we will select the appropriate form of support in consultation with you, for example:

  • Document review of e.g. your submission documents or your QM system.
  • "Mock audit" as preparation for an FDA inspection.
  • Telephone and email responses to your question.
  • Creation of your documents.
  • Supervise your registration/listing e.g. via web conference .

Find out how we can complete a project together

Interested? Then do the following

Give us a call, send us an email or fill out the contact form so we can

  • understand your task,

  • if required, agree a confidentiality agreement,

  • prepare a tailor-made offer and

  • support you as quickly, competently and cost-effectively as possible.