Medical Devices and IVDs
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?
We Offer Custom Training
NSF Health Sciences Journal: Time to Rethink - Issue 47, 2020
July 31, 2020
Webinar: Reopening Your Business and the Use of Face Masks
June 5, 2020
This video from Kim Trautman at NSF International covers the use of face masks and the requirements of several different governing agencies including OSHA, U.S. FDA, Health Canada and NIOSH. She reviews several different masks to help you choose the appropriate one for your business and personal use.
Webinar: Make Hand Sanitizer, Not Mistakes: Understand the FDA Policy
May 13, 2020
If your company is new to making hand sanitizer, our experts can help you understand the U.S. regulatory requirements and get your product on the market. We guide you through the U.S. FDA’s temporary guidance documents for manufacturing alcohol-based hand sanitizers during the COVID-19 public health emergency. We will assist you with the FDA establishment registration and product listing. If your company is based outside the U.S., we can also act as your U.S. agent.
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
NSF International EVP Kim Trautman Appointed to Regulatory Affairs Professionals Society Board
January 28, 2020