SERVICES

Medical Device Quality 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 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.

Knowledge Panel

November 6, 2020

What I’ve Learned from 20 Years in the Medical Device Industry

July 29, 2020

What to Look for in a Medical Device Quality and Regulatory Compliance Consulting Partner: The Definitive Checklist

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