Medical Device and IVD Solutions

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.

• In Vitro Diagnostic Regulation (EU IVDR)

• Developing and Improving Medical Device Quality Management Systems

• Finding Solutions

• Getting Ready for Medical Device Market

• Our Experts

• Training

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.

Learn more about our training

News and Events

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.

European Commission Puts the Delay to EU MDR Transition Timelines to the Vote

January 11, 2023

The European Commission published its proposal paper on the transition provisions for medical devices and in vitro diagnostic medical devices on January 6, 2023, it sets out the new transition deadlines and is a must read for the MedTech industry.

European Commission Proposes Delay to EU MDR Transition Timelines

December 20, 2022

Since the EU MDR came into force in 2017, large parts of the MedTech industry and notified bodies have warned that the capacities of the notified bodies to issue new certificates could become the decisive bottleneck for the implementation of the EU MDR and the EU IVDR. This fear has solidified in the last five years.

See More News