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

White Paper: Tools and Tips for Writing Effective Nonconformity Statements During Quality Management System Audits of Medical Device Manufacturers

As a medical device quality management system auditor, one of the most important (if not the most important) responsibilities of your role is to effectively communicate identified nonconformities to the auditee organization.

Two of the Most Common IVDR Challenges (With Solutions)

Learn more about two of the most common challenges for IVD manufacturers in meeting IVDR compliance: performance evaluation and post-market requirements.

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.

News and Events

Pharma Pipeline at All-Time High

May 6, 2022

More than 20,000 products are under active development. Find out more about the latest report and what else is happening in NSF’s May 2022 news update.

MDCG 2022-2 Guidance on General Principles of Clinical Evidence for IVDs

March 28, 2022

MDCG 2022-2 on performance evaluation provides information on collecting, generating, documenting, and continuously updating clinical evidence for IVD products.

The State of Pharma Quality, GMP Certificates, November Pharma News Update

November 9, 2021

NSF looks at the legislative and regulatory changes in the pharmaceutical sector in November 2021.

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.

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