Quality Management in Medical Devices industry

Cost of poor Quality:
The medical device industry has in the recent years been affected of several product quality incidents. These incidents have impacted patient health but also caught media attention and caused negative brand image and investor relations.  The medical device product development life cycle operates under complex regulations and cost to compliance is critical.

Quality Management is significant for the industry in order to meet international and national regulations but also to meet and exceed customers’ expectation. If the appropriate quality management system is not fully implemented including a proactive quality mind-set throughout the company several issues can arise. One such issue is the cost of poor quality. The illustrative picture of the quality iceberg can be a good starting point to understand the issue: The visible part of cost of poor quality is defects, rework or scrap. Below the surface causes such as revenue loss to sales, culture behaviour and attitudes, loss reputation in market and customer dissatisfaction is less visible.

The next steps:
In today’s competitive business cost of poor quality can be fatal for companies operating in the medical device industry. In this articles reading list, we will recommend three readings for professionals in this industry in order to get a better understanding of cost of poor quality.

1. The Business Case for Medical Device Quality
A study investigating the financial impact of cost of poor quality (Fuhr, George and Pai,2013).
2. Preparing for the future: The new European Union Medical Device Regulation
An introduction into the new European regulations. The report is conducted by the multinational professional services company Deloitte.
3. Implementing ISO 130485 Medical Devices Quality Management System
A seminar describing how to implement and work with ISO 130485 Quality Management System (Evans, 2013)


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