Many of our experts are former regulators who will prepare and train your team through remediation, consultation, mock inspections, gap analyses and more. We also provide expert advice for ensuring compliance with international regulations and standards, implementing effective quality systems and mitigating risk as you bring new and innovative products to market.
Explore Solution Areas
Nitrosamine Impurities; What’s the Impact on IMPs
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.
Safety Risk Management, a Framework for Developing and Implementing Rems Modifications and Revisions
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.
NSF International Announces Updated GMP Standard for Pharmaceutical Excipients
April 16, 2020
The NSF/IPEC/ANSI 363-2019: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients standard has been revised to align more closely with the structure of ISO 9001:2015 (EN) Quality Management Systems – Requirements.
Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDA
April 2, 2020