Addressing Medical Device Quality Systems

Receive tailor-made solutions for your specific needs, including a defined quality plan with program management guidance.
A young female engineer repairs a faulty medical device - Developing and Improving Quality Management Systems | NSF

NSF's medical devices experts offer comprehensive solutions for quality management systems (QMS) support. We assist clients with QMS development and establishment, optimize an existing QMS, provide gap assessments and develop remediation plans that address the entire product lifecycle.

We create programs that address all systems, including:

  • Investigations, CAPA and root cause analysis
  • Quality management system development
  • Standard operating procedure (SOP) development
  • Design controls
  • Retrospective review of DHF / DMR
  • Technical review of processes to close identified gaps and align with improvement expectations
  • Risk management analysis and review
  • Software validation
  • Purchasing controls
  • Vendor management and oversight
  • Cost of poor quality analysis across sites and systems

Ready to Begin the Process?

Contact us with questions or to receive a quote.

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’s Health Sciences Team Joins Fight to Save Lives With More Ventilators

April 23, 2020

NSF’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.

March 2023 Pharma News Update

March 1, 2023

The U.S. NIST has developed a framework to better manage risks to individuals, organizations and society associated with artificial intelligence (AI).

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.