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

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

Key Updates on the European Medical Device Market – June to September 2020

Expert Lukas Block details some of the guidance documents published by the Medical Device Coordination Group, including Guidance MDCG 2020-14, explaining how notified bodies can use MDSAP audit reports for MDR/IVDR surveillance audits.

U.S. Medical Devices Regulatory Update – July to September, 2020

NSF’s medical devices regulatory consulting team highlights key FDA guidance documents for medical devices issued in the third quarter of 2020.

Regulatory Q&A Session With NSF Experts

Following their presentations at the MedTech Virtual Event in October 2020, NSF experts Oliver Christ, Kim Trautman and James Pink host a Q&A session to answer your questions on topics including the EU MDR, the regulation in relation to COVID-19 and quality management systems.

News and Events

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.

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

See More News