3 Key Non-Compliance Warning Signs in Medical Device Design

In a recent article that appeared on Med Device Online, Susan Gould, of the Halloran Consulting Group weighed in on potential regulatory compliance pitfalls and how to spot the warning signs before your company is looking at multiple 483s.

Avoid these Potential Pitfalls in Medical Device Quality Control

In the article, Gould recalls a quarterly management meeting wherein a project review showed green, yellow and red dots throughout, which highlighted the level of compliance in the medical device quality control process. The team dug into the red dot issues extensively and walked away from the meeting with several action items to resolve the issues. The green dots were celebrated. The yellow dots were regarded as things to watch as the project progressed.


Three months later,” Gould states, “the company had the pleasure of hosting an FDA inspection — resulting in multiple 483s indicating our quality system was not operating as the FDA expected.” She thought there may have been some areas for improvement, as with most companies, but wondered how the group could have missed warning signs that resulted in so many 483s.  

I believe that experience is similar to what many companies face,” she states. “It is rarely, if ever, an issue of gross negligence or incompetence, as most firms are filled with dedicated and motivated personnel who believe in their products and come to work wanting to do the right thing… yet the Agency drops in and finds compliance issues that seemingly were not identified by the internal system.” 

Gould identifies three warning signs and describes how these yellow-dot issues can turn into major compliance failures if ignored. Below is an overview of the 3 key compliance issues. Click here to read the complete original article.

3 Compliance Issues to Watch for in Medical Device Development

1. Over-Reliance On Standard Compliance Metrics

This essential data is the basis for developing a 'standard' set of quality system reporting slides, often shown in graphs and tables with little context or actionable information…  These metrics often fail to provide early signals of product and process quality issues. 

2. Ineffective Management Reviews 

Rarely do I meet people who look forward to a management review meeting. However, the frequency and timing of management review meetings can be a warning sign of compliance issues,” she states. Regulatory inspectors “want to see that you are regularly checking the health of your quality system (and products), asking the right questions, and challenging assumptions, as well as verifying that the firm has committed the necessary resources to collect, analyze, and interpret quality system data. 

3. When Quality Is A Function, Not A Culture

Gould acknowledges that it’s common and, in fact, imperative for engineering and manufacturing companies to regard quality as a standard and specific function within an organization. There must be a hierarchy in medical device quality control, starting with the Head of Quality, along with strict procedures and a trained staff in place. “However, when quality is viewed only as a specific function, and not a core part of the organization’s culture,” she states, “…employees start to believe that quality is not each individual’s responsibility.

At KMC Systems, quality assurance and regulatory compliance in medical device design and manufacturing is much more than a set of procedures and standards, it truly is our culture. Quality is at the heart of everything KMC Systems does. KMC operates an FDA-inspected site and undergoes numerous industry audits every year. Our robust, FDA-compliant, automated software system has been customized over three decades to adhere to our strict processes and complex applications which ensures greater adherence to regulatory requirements. The resulting KMC Quality Management System (QMS) enables our QA team to adhere to regulatory requirements with confidence and proven success.

To learn more about KMC's approach to quality assurance and regulatory compliance, visit our quality assurance web page or click below to download the medical device quality assurance tip Sheet. If you'd like to speak with a member of the KMC Systems team about your instrument design project, click here to contact us


Read the blog: The Role of Quality Assurance in Medical Device Design 

Topics: medical device quality assurance, medical manufacturing quality management