FDA Consultants Medical Devices
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If you need to…
- Clear your device through FDA
- Perform internal audits because FDA or your Notified Body will inspect your facility
- Respond to an FDA-483
- Upgrade to ISO 13485: 2016
- Implement a Quality Management System
- Conduct or close out a Medical Device Recall
We can help! With over 20 years of experience in the medical device quality assurance and regulation industry, as FDA Consultants Medical Devices, we can assist you with…
- Writing 510(k)s for complex electromechanical devices and Software as a Medical Device.
- Doing your FDA and ISO internal Quality Audits.
- Responding to FDA and ISO inspection observations by creating remedial action plans.
- Writing, implementing, managing, and defending ISO, FDA, CMDCAS quality systems.
- Implementing fully compliant Quality Management Systems in three weeks or less.