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Medical Devices and IVDs - Finding Solutions

A female scientist in a laboratory working on microscope - Medical Device Remediation Support Services | NSF
Respond to adverse regulatory inspection findings, build a compliant quality system and avoid future problems with a custom remediation plan.

Wherever you are in the product lifecycle, NSF provides solutions and expert guidance. Conduct rescue trials, respond to adverse regulatory inspection findings, build a compliant pharmaceutical quality system or create effective corrective and preventive actions (CAPAs) as part of your remediation plan.

How Can We Help?

NSF Remediation Support Services

Receive expert guidance in product development, market application, manufacturing, distribution and continuous monitoring of your medical devices, IVDs and combination products.

Recall Strategy

Optimize your recall strategy by using NSF experts to identify gaps in your processes against industry best practices. We'll make strategic recommendations and help you establish benchmarks for success.

Post-Inspection and Post-Market Response

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

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.

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Working With the FDA on Medical Device Recalls | NSF

Working With the FDA on Medical Device Recalls

Ashley Kelleher, Senior Medical Device and IVD Consultant at NSF, talks about working with the FDA on medical device recalls.

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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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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.