In medical device development, a good Quality Assurance Process is critical to ensuring that the device is safe and meets requirements. Having a Quality Assurance Team experienced in verification strategy, protocol development and execution will increase product quality, and mitigate project risk; saving time and additional costs associated with program delays.

A partnership between Quality Assurance and Development is essential to achieving high value out of the verification effort. This session includes strategies you can employ to reduce friction in the verification effort and to help mitigate any impact on cost and schedule. 

Listen to Trisha Bouthot, Director of Quality and Test, and Dave Hibbard, Director of Programs, both of Sunrise Labs, share key tips from their experience in product verification efforts. 

Key Takeaways:

  • Best practices in the development and execution of verification plans and protocols
  • Tailoring verification plans based on project needs, risk profile, and regulatory strategy 
  • Strategies to help mitigate schedule impact and risks when verification start is delayed 
  • The benefits of planning for verification early in a project 
  • Implementation of Agile methodologies with continuous code review/integration testing

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