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Medical Device and IVD Solutions

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

US FDA Regulations

MDSAP, ISO 13485 and FDA Mock Inspections

Remediation and Product Recall Services

Regulatory Affairs

Quality Management Systems

Medical Device Regulation (EU MDR)

In Vitro Diagnostic Regulation (EU IVDR)

Training and Education

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

To find out more about our consulting, training and auditing services.

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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

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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

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.

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.

World Quality Week Q&A With Quality Management Expert Janet Book

NSF celebrates World Quality Week with a special Q&A with quality management expert Janet Book, Principal Consultant for Medical Device Consulting

News and Events

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.

November 2022 Pharma News Update

November 1, 2022

The November 2022 pharmaceutical news update looks at the EMA/HMA draft consultation on a data quality framework for EU medicines regulation. It also looks at revised U.S. FDA guidance on the physical attributes of generic tablets and capsules.

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