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Post-Inspection and Post-Market Response

Draft and submit regulatory responses and reports with the assistance of our highly experienced, global regulatory experts.
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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.

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Contact us with questions or to receive a quote.

Resources

Mobile phone with digital health application diga - Germany focuses on digital health applications (DiGAs)

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.

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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.

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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.

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News and Events

Doctor tapping on screen with technology - Medical Device and IVD News Update | NSF

March 2023 Medical Device and IVD News Update

March 1, 2023

Welcome to our March Medical Device and IVD news update. Every month we'll bring you the latest medical device and IVD industry news, useful articles and resources, expert advice, training, and events for your calendar.
Doctor tapping on screen with technology - Medical Device and IVD News Update | NSF

January 2023 Medical Device and IVD News Update

January 23, 2023

Welcome to our new Medical Device and IVD news update. Every month we'll bring you the latest medical device and IVD industry news, useful articles and resources, expert advice, training, and events for your calendar.

March 2023 Pharma News Update

March 1, 2023

The U.S. NIST has developed a framework to better manage risks to individuals, organizations and society associated with artificial intelligence (AI).

February 2023 Medical Device and IVD News Update

February 15, 2023

This month we'll look at key FDA policies, procedures, and practices before, during and after inspections, provide tips for writing effective nonconformity statements during QMS audits, and more.
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