Getting Ready for Medical Device Market
Work with our team of former regulators and industry experts to audit your quality systems, conduct clinical trials, prepare for inspections and file regulatory submissions in order to bring your products to market.
How Can We Help?
NSF offers a variety of mock audits to help you ensure regulatory readiness. Assess a wide range of regulatory requirements to identify areas of risk and perform due diligence activities, or rely on NSF to support your internal and supplier audit programs.
Global Regulatory Strategy and Submissions
Receive your customized regulatory strategy from our team of former regulators and technical experts to efficiently bring innovative medical devices, in vitro diagnostics and combination products to market.
Clinical Trial Support
NSF provides efficient, effective clinical trial support and product development strategy. We help you optimize time and cost throughout the process while maintaining the highest levels of quality, integrity and scientific excellence.
Schedule a mock audit or readiness inspection to prepare your team for the regulatory audit and inspection process.
Insights and Expertise
White Paper: Tools and Tips for Writing Effective Nonconformity Statements During Quality Management System Audits of Medical Device Manufacturers
Key FDA Policies, Procedures and Practices Before, During and After Medical Device Manufacturer Inspections
NSF Health Sciences Journal: Time to Rethink - Issue 47, 2020
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.
January 2023 Medical Device and IVD News Update
January 23, 2023
European Commission Puts the Delay to EU MDR Transition Timelines to the Vote
January 11, 2023
European Commission Proposes Delay to EU MDR Transition Timelines
December 20, 2022