Home Health Sciences Medical Device and IVD Solutions Medical Devices and IVDs - Finding Solutions Post-Inspection and Post-Market Response

Post-Inspection and Post-Market Response

Draft and submit regulatory responses and reports with the assistance of our highly experienced, global regulatory experts.
A female scientist in a laboratory working on microscope - Medical Device Remediation Support Services | NSF

Our team has years of experience helping clients successfully address regulatory exchanges, including responses to inspection or audit findings, warning letters, regulatory agency deficiency letters or additional information letters, adverse event follow-up requests and other post-market regulatory correspondence and required reporting.

Ready to Begin the Process?

Contact us with questions or to receive a quote.

Resources

Mobile phone digital health application diga 132326956

Germany Focuses on Digital Health Applications (DiGAs)

Read our article in the Journal of Medical Device Regulation on data protection and security and the positive care effects of digital health applications.

Read more

A man pointing the pen on the paper - 10 Tips to Effective FDA 483 Responses: Medical Devices | NSF

Ten Steps to an Effective Medical Devices FDA 483 Response

Well documented FDA 483 observations can support FDA official actions. An effective and timely response to FDA 483 observations may help your organization avoid such actions.

Read more

A close-up image of an elderly hand holding a globe - NSF Health Sciences Journal: Time to Rethink - Issue 47, 2020 | NSF

NSF Health Sciences Journal: Time to Rethink - Issue 47, 2020

This edition of the health sciences Journal is about hope and optimism, and how we must rethink our ways of working.

Read more

1 of
See More

We're Here To Help

To ensure impartiality, use of NSF management systems consulting services or attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.