Developing and Improving Quality Management Systems

Establish, maintain or remediate your quality management system with the help of our expert consultants.

How Can We Help?

Addressing Medical Device Quality Systems

Receive tailor-made solutions for your specific needs, including a defined quality plan with program management guidance.

Data Integrity Support for Medical Device and IVDs

Assess a wide range of regulatory requirements to identify areas of risk and support your internal or supplier audit programs.

Meeting and Complying With Regulations

Achieve sustainable and compliant quality management systems with our expert team of former regulators and technical experts.

Facilities, Equipment and Technical Support

Receive expert guidance and technical support on everything from product optimization and device labeling to facility design, equipment qualification and process validation. We support both manufacturing and distribution services.

Resources

Germany Focuses on Digital Health Applications (DiGAs)

Read our article in the Journal of Medical Device Regulation on data protection and security and the positive care effects of digital health applications.

Insights and Expertise

World Quality Week Q&A With Quality Management Expert Janet Book

NSF celebrates World Quality Week with a special Q&A with quality management expert Janet Book, Principal Consultant for Medical Device Consulting

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.

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News and Events

Pharma Pipeline at All-Time High

May 6, 2022

More than 20,000 products are under active development. Find out more about the latest report and what else is happening in NSF’s May 2022 news update.

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.

March 2023 Medical Device and IVD News Update

March 1, 2023

Welcome to our March 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.

February 2023 Medical Device and IVD News Update

February 15, 2023

This month we'll look at key FDA policies, procedures, and practices before, during and after inspections, provide tips for writing effective nonconformity statements during QMS audits, and more.

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