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Medical Device and IVD Solutions

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Let NSF take you further with consulting, training and auditing services for medical device, IVD and combination product manufacturers.

Mitigate risk, ensure compliance with international and FDA regulations and standards, and apply effective quality systems with expert advice from NSF.

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We Can Also Help With

  • Project Management
  • Acquisition Diligence Support
  • Distribution Service Audits
  • Risk Management Systems
  • Technical Documentation
  • Clinical Affairs
  • Biological Safety
  • Trustee Service
Our Consultants have been in your shoes and are here to help you on your journey to better compliance.
Sarah Moore
Director of Global Medical Device and IVD Consulting

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Our medical device, IVD, and combination product experts can help you to bring new and innovative products to market.
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Our interactive training courses are based on real-world scenarios and designed to help you meet international requirements, no matter where you are located.
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Resources

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

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

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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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News and Events

Regulatory Affairs Professionals Society (RAPS) Convergence 2023 | NSF

Join NSF at RAPS Convergence 2023

September 12, 2023

This year’s gathering of regulatory affairs professionals will take place in Montréal, QC Canada on October 3–5, 2023.
Doctor tapping on screen with technology - Medical Device and IVD News Update | NSF

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.

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.
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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.