A group of medical practitioners are conversing in a hospital corridor - Global Regulatory Strategy and Submissions | NSF

Getting Ready for Medical Device Market

Prepare for market launch by conducting clinical trials, developing regulatory filing strategies and ensuring inspection readiness through training and auditing.

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?

Performing Audits

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.

Inspection Readiness

Schedule a mock audit or readiness inspection to prepare your team for the regulatory audit and inspection process.

Resources

Insights and Expertise

White Paper: Tools and Tips for Writing Effective Nonconformity Statements During Quality Management System Audits of Medical Device Manufacturers

As a medical device quality management system auditor, one of the most important (if not the most important) responsibilities of your role is to effectively communicate identified nonconformities to the auditee organization.

Key FDA Policies, Procedures and Practices Before, During and After Medical Device Manufacturer Inspections

This paper by expert Rob Ruff provides a behind-the-scenes look at how FDA medical device inspections are planned, conducted and managed.

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.

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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

Welcome to our new Medical Device and IVD news update. Every month we'll bring you the latest medical device and IVD industry news, useful articles and resources, expert advice, training, and events for your calendar.

European Commission Puts the Delay to EU MDR Transition Timelines to the Vote

January 11, 2023

The European Commission published its proposal paper on the transition provisions for medical devices and in vitro diagnostic medical devices on January 6, 2023, it sets out the new transition deadlines and is a must read for the MedTech industry.

European Commission Proposes Delay to EU MDR Transition Timelines

December 20, 2022

Since the EU MDR came into force in 2017, large parts of the MedTech industry and notified bodies have warned that the capacities of the notified bodies to issue new certificates could become the decisive bottleneck for the implementation of the EU MDR and the EU IVDR. This fear has solidified in the last five years.

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