Continuous monitoring of metrics in medical device field
Wiik-Miettinen, Fanny (2024)
2024
All rights reserved. This publication is copyrighted. You may download, display and print it for Your own personal use. Commercial use is prohibited.
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:amk-2024111328042
https://urn.fi/URN:NBN:fi:amk-2024111328042
Tiivistelmä
Continuous monitoring of metrics in medical device field The medical device and in vitro diagnostic sectors are significant and growing industries in Finland. Fields are regulated by EUs IVDR regulation and international standards like ISO 13485. Continuous measuring and monitoring of key product quality metrics and the effectiveness of the quality management system is not only required but also crucial for ongoing improvement.
Product quality metrics include the number of complaints, non-conformances, issue severities, and fault categories, while QMS effectiveness metrics measure aspects such as the closure rate and speed of complaint resolution. Regulatory requirements for medical devices necessitate periodic post-market surveillance. International standards and regulations mandate several actions from medical device companies to demonstrate responsibility and vigilance. Manufacturers must gather, monitor, and act on feedback, implementing corrective and preventive actions (CAPA).
This thesis aims to develop a process for continuously monitoring key product quality and QMS effectiveness metrics for a biotechnology company producing IVD instruments and products. The goal is to automate and synchronize the data gathering process for these metrics, ensuring alignment with the needs of various stakeholders. By analysing fault categories and other attributes, the thesis seeks to enhance understanding of product quality and streamline the review and reporting process, potentially automating or semi-automating data pools.
Product quality metrics include the number of complaints, non-conformances, issue severities, and fault categories, while QMS effectiveness metrics measure aspects such as the closure rate and speed of complaint resolution. Regulatory requirements for medical devices necessitate periodic post-market surveillance. International standards and regulations mandate several actions from medical device companies to demonstrate responsibility and vigilance. Manufacturers must gather, monitor, and act on feedback, implementing corrective and preventive actions (CAPA).
This thesis aims to develop a process for continuously monitoring key product quality and QMS effectiveness metrics for a biotechnology company producing IVD instruments and products. The goal is to automate and synchronize the data gathering process for these metrics, ensuring alignment with the needs of various stakeholders. By analysing fault categories and other attributes, the thesis seeks to enhance understanding of product quality and streamline the review and reporting process, potentially automating or semi-automating data pools.