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

Medical Devices and IVDs - 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.

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

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

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

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.

News and Events

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.

The 11th Northern German Dialogue – Symposium on Medical Technology

August 17, 2022

NSF has once again partnered with Life Science Nord for our 11th Symposium on Medical Technology, which will take place September 15-16, 2022.

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.

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