Medical Devices and IVDs

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

Establish, audit or remediate your quality systems with guidance from our team of former regulators. Our experts help you prepare for market, mitigate risk and achieve sustainable compliance with country-specific regulations and international standards.

How Can We Help?

Developing and Improving Quality Management Systems Establish, maintain or remediate your quality management system with the help of our expert consultants.

Getting Ready for Market Prepare for market launch by conducting clinical trials, developing regulatory filing strategies and ensuring inspection readiness.

Finding Solutions Respond to adverse regulatory inspection findings, build a compliant quality system and avoid future problems with a custom remediation plan.

Training and Education Bring about change that drives improvements.

Are You Ready for the In Vitro Diagnostic Medical Device Regulation (IVDR)?

Make sure your IVD complies with the IVDR requirements so it can remain on the market after the transition period ends on May 26, 2022.

Prepare with our free resources

Support During COVID-19

Our team is here to help you and the health care industry through these uncertain and fast-moving times.

Learn more about our services and support

Emergency Use Authorization Services

Our team can help you determine the appropriate pathway for your device and navigate the EUA process.

EUA Support Services for the Medical Device Industry

We Offer Custom Training

Training audience with woman raising hand

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

Resources

An Easier Approach to IVDR Technical Documentation

Before placing in vitro diagnostic (IVD) devices on the market, most manufacturers will need their technical documentation assessed by a notified body.

ISO 10993-23: The "Step-Wise" Approach to Evaluate Potential Irritants in Medical Devices Becomes Effective

Biological safety evaluation is an important piece of the puzzle to demonstrate the overall safety of a medical device. ISO 10993-23:2021 is a new standard that specifies procedures for assessing the irritation potential of medical devices, materials or their extracts.

Key FDA Policies, Procedures and Practices Before, During and After Medical Device Manufacturer Inspections

This paper by expert Rob Ruff provides a behind-the-scenes look at how FDA medical device inspections are planned, conducted and managed.

News and Events

Meet NSF at Making Pharma 2021

August 31, 2021

NSF's health science experts will attend Making Pharma 2021, one of the UK’s largest pharmaceutical conferences and exhibition events.

Are You a Medical Device and IVD Expert? Join Our Consulting Team!

August 9, 2021

We're recruiting! NSF has several open consulting roles across the globe. We would love to chat with you about your experience and discover how you could be an asset to our organization.

NSF Launches New IVD App

January 18, 2021

NSF International announces the release of its new in vitro diagnostics (IVD) app, available to download for free on Apple’s App Store and Android’s Google Play.

NSF Health Sciences Podcasts – Access Expert Content On-the-Go

October 22, 2020

Access a wealth of free podcasts and webinar recordings from our pharma and medical devices experts to help you make better business decisions and stay up to date with the latest industry trends.

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