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.

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

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

EU MDR: What Does It Mean for the Medical Device Industry?

Kim Trautman looks at the key changes occurring with the EU MDR, including additional post-market surveillance. She explores how companies can prepare for the May 2021 deadline, including ways in which NSF can offer support.

Webinar: A Regulatory Q&A With IVD Expert Robyn Meurant

Robyn Meurant, NSF’s in vitro diagnostic (IVD) expert, answers your questions on IVD Regulation (EU) 2017/746 in the lead up to the May 26, 2022 deadline.

NSF Health Sciences Journal: Time to Rethink - Issue 47, 2020

This edition of the health sciences Journal is about hope and optimism, and how we must rethink our ways of working.

News and Events

NSF Now Offering Live Instructor-Led Virtual Pharmaceutical and Medical Devices Training

May 19, 2020

To complement its face-to-face offering, NSF now offers traditional classroom courses as virtual instructor-led training to support your professional development. Courses are delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. NSF’s coaches are on hand to guide participants through the interactive sessions which also include pre- and post-course activities.

NSF International’s Health Sciences Team Joins Fight to Save Lives With More Ventilators

April 23, 2020

NSF International’s health sciences team is hands-on in the rapid ventilator manufacturing specification issued by the United Kingdom (UK) government. The UK National Health Service needs thousands more ventilators to help save lives as the country’s COVID-19 pandemic approaches its expected peak and ventilator capacity becomes a challenge.

Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDA

April 2, 2020

Submissions include an IND, IND Amendment and Compassionate Use Approval for CytoDyn’s product Leronlimab, a Compassionate Use Approval for a treatment device, and an EUA for a PCR-based IVD for COVID-19 detection

NSF International EVP Kim Trautman Appointed to Regulatory Affairs Professionals Society Board

January 28, 2020

NSF International’s Trautman joins a team of global leaders guiding the independent, non-profit organization supporting and leading the profession through an increasingly complex regulatory environment

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