Addressing Medical Device Quality Systems
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.
Insights and Expertise
World Quality Week Q&A With Quality Management Expert Janet Book
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.
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.
Inspired by Purpose
December 2, 2022
ESG Reporting Developments: Regulatory, Voluntary and How to Prepare
November 3, 2022
Join NSF’s experts for a webinar on November 9 that will cover current and impending global regulations and market-driven requirements for comprehensive Environmental, Social and Governance (ESG) reporting.