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