Medical Device Remediation Services
The last thing any medical device
manufacturer wants to receive is an FDA form 483 or FDA
warning letter. Are you
prepared to handle the implications of Form 483 and/or a
warning letter? REU Associates can assist with the development
and implementation of a warning letter remediation plan to
bring your company into full compliance. Our remediation
solutions will help your organization:
Analyze the results of the FDA 483 and/or
FDA warning letter.
Formulate an effective response to an FDA
483 and/or warning letter.
Arrange a timeline to meet agency
Develop a remediation plan to identify
all causes for deficiencies.
Answer any of your questions or questions
from the FDA.
Implement improvements to ensure total
REU Associates will help you navigate the
FDA regulatory process and make sure your company meets all
requirements for product clearance and approval. With vast
experience in the medical device industry, REU Associates has
the leadership, expertise and tools necessary to generate
complete FDA compliance so you can return to business as