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ASQ SFV 706 May Event: Customer-Focused Medical Device Management Review
Ali Baba Restaurant - Banquet Room
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Beyond Internal Metrics: Customer-Focused
Medical Device Management Reviews
Presented by: Monica Daneshrad
The management review cadence evaluates the efficacy of the quality system against key performance indicators or metrics established by leadership. Timeliness of activities such as customer feedback, training, and internal audits are reviewed robustly; however, there is still an opportunity to actively address the needs of the customer. Understanding the needs of the customer allows the company to deploy resources and solutions to reported complications of breast implants and cardiac ablation procedures. The tools that allow for this understanding are based upon the Law of the Market and the Law of Focus. Information from different channels can be aggregated via quality management tools such as affinity diagrams, interrelationship digraphs, and impact effort matrices. Links between various ailments and product design have been found, using these tools. Information from available channels of customer communication can be leveraged to further reduce reporting of signals due to product improvement.
By attending this clinic presentation, you will:
- Understand the current state of medical device management review body of knowledge.
- Apply certain quality management tools to further understand product issues and impactful solutions.
Our speaker: Monica Daneshrad
Monica Daneshrad is a Senior Quality Engineer currently employed in the medical device division at Johnson & Johnson in Irvine. She has accrued eleven years of experience in the quality systems field having worked at companies such as Siemens and Allergan. She has implemented and led process improvement initiatives in Document Control and Internal Standards. She currently supports management reviews for 7 Johnson & Johnson brands.
Monica holds a Bachelor’s of Science in Biology/Spanish with a minor in English from Loyola Marymount University. She has the following ASQ Certifications: Yellow Belt, Green Belt, Black Belt, and Manager of Quality/Organizational Excellence. She holds a Project Management Certificate from UC Berkeley and is an MSQA Candidate at California State University-Dominguez Hills.
Please join us!