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Medical Device and IVD Solutions

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Bring innovative medical device, IVD and combination products to market with our auditing, consulting and training services.

Our experts can help you throughout the product lifecycle to ensure compliance with international regulations and standards, prepare quality management systems, mitigate risk, deal with gap analysis and correction actions for remediation, provide acquisition diligence support and more.

Training, Consulting and Auditing Services

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

Contact Us Today To Get Started

To find out more about our consulting, training and auditing services.
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Get the latest Medical Device and IVD industry news straight to your inbox each month as well as useful articles and resources, expert advice, training and events for your calendar.
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Our Experts

Our medical device, IVD, and combination product experts can help you to bring new and innovative products to market.
Meet our experts

We Offer Custom Training

The Right Training for Your Team
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.

Read more

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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

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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