solutions

Quality Assurance

Quality should feel like tailwinds, not headwinds.

By embedding right-sized quality management systems with design controls, documentation and compliance discipline early, you can reduce costly rework, protect your timeline, and strengthen investor and regulatory confidence. 

We can also proactively prepare with quality training and internal audits, mitigating risk, while managing unexpected crises should they arise. With Avio as your co-pilot, you are prepared for turbulence before it hits and have a partner to navigate you through the storm.

#1 


Quality System Implementation

  • QMSR gap assessments and implementation
  • ISO 13485 and MDSAP readiness
  • SOP development and documentation control
  • Design controls and DHF/DDF oversight
  • Risk management framework development 

#2 


Ongoing Quality Leadership

  • Supplier quality management and oversight
  • CAPA system implementation and management
  • Management review support
  • Quality training programs
  • Internal audit program development and execution
  • QMSR scaling for growth
  • FDA, MDSAP, Notified Body audit support
  • Post-market complaint handling and recall support
  • Untitled Letter and Warning Letter response support

Thanks to Avio, we not only gained a comprehensive understanding of the regulatory landscape but also successfully navigated through the rigorous process of MDSAP certification. This major milestone wouldn’t have been possible without their support and expertise. Their tailored approach, attention to detail, and guidance have been instrumental in ensuring compliance at every stage.” 


Dr. Don Vaughn, Ph.D.
 


Co-Founder, Ampa Health

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