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.

To ensure impartiality, use of NSF management systems consulting services or attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.