Medical Device Quality Systems Consulting

Lean into our quality systems know-how.

A robust quality system is critical to the success of your business.

Our team of experts analyzes your needs and objectives to develop pragmatic, disciplined quality systems and strategies. With clear and concise documentation, we prepare clients to pass audits and avoid future roadblocks.

We have medical device quality systems consultants ready to work with you on custom-tailored solutions for:

  • Audits
  • Design verification and validation
  • Post-production compliance
  • Project management
  • Quality management system (QMS) development and implementation
  • Quality system training
  • Risk management
  • Process Validation
  • Unique device identification (UDI)
  • Virtual document control
  • Quality Assurance Unit (QAU) for Good Laboratory Practices (GLP) Studies

QA Consulting can work with your business as your outsourced Quality department or we can work with you to educate or train your team on industry best practices.

Learn More About Our Medical Device Expertise

Knowledge Panel

May 9, 2022

Quality Spotlight Webinar: Trials and Triumphs of Complaint Handling

April 22, 2021

Mind the Gap: Is it Time for a Medical Device Gap Analysis?

Have a specific quality need not listed above?

Let us know. Our diverse team of experts is available to discuss and advise.

Looking to quickly expand your organization’s quality capabilities? Consider outsourcing some or all of your quality functions.

Set up a discovery call