Medical Device Design: How Well Are Your Quality System Organizational Responsibilities Managed?
Marci L. Crane
April 26, 2008
There are a variety of ways to start off on the wrong foot.
From cutting across the wrong lines in kindergarten to appearing too anxious on a first date; everybody knows that first impressions and first endeavors really count.
For medical device companies the principle of starting out right is extremely essential because medical device companies literally hold human lives in their hands. So how can med device companies always start out right? The answer is by controlling their quality systems and especially, their design processes.
Why Design?
You might wonder why design would be the most important aspect (or at least the most crucially determinate) aspect of quality system management for a medical device company. Even the FDA in past decades paid less attention to design concerns and focused on manufacturing. That changed however when serious errors began to occur and an FDA recall study found that "44% of medical device recalls [were] due to design problems,"1 which makes it abundantly clear that design mishaps are not only a headache for the FDA but are primarily detrimental to the medical device companies themselves.
Design Control Guidance for Medical Device Manufacturers
Since the FDA´s discovery regarding the important nature of design, the FDA has created regulations as aspects of the FDA Quality System regulations (21 CFR Part 820). These design-focused quality system regulations can also be compared to those standards documented in ISO 9001 quality system related content.
To make these design-related regulations clear and understandable for a variety of design control professionals, the FDA has released a Design Control Guidance for Medical Device Manufacturers. The guidance contains a variety of information regarding development planning, design input, design output, design review design verification, etc.
Each of these topics merit some discussion but the remainder of this article will focus on a topic that is likely to influence all aspects of design control and in turn the entire quality system.
Quality System: Design Related Organizational Responsibilities
The organization responsibilities for quality system design requirements can be found in the QS regulation documentation in the management section. This aspect of the regulations, like most life science regulation facets, is flexible to every company´s unique circumstances. According to the design guidance, "The management responsibility section of the quality system requirements requires management to establish a quality policy and implement an organizational structure to ensure quality."2 This of course means that it is the medical device company´s duty to ensure that organizational responsibilities are well documented and that training related to organization responsibilities is very clear. Some companies may even want to participate in quarterly trainings to keep development plans "on the brain."
All of these quality system tips may sound simple to accomplish but it isn´t enough to simply define and document those who have organizational responsibilities and then follow those tasks with training courses. Instead, interface events, interrelationships between responsible parties/individuals as well as their authorities and responsibilities need to be "defined, documented, coordinated, and controlled." According to the FDA´s design guidance:
"This might be the case, for example, if a multidisciplinary product development team is assembled for a specific project, or if the team includes suppliers, contract manufacturers, users, outside consultants, or independent auditors."3
Conclusion
It is essential that representatives from medical device companies not only be familiar with organizational responsibilities regarding design control but that they also familiarize themselves with the Part 820 quality system regulations in general.
1 http://209.85.173.104/search?q=cache:DUvhKcooGCEJ:www.cs.umd.edu/hcil/about/events/open-house-2004/SOH04Carstensen.ppt+%2244%25+of+medical+device+recalls+due%22&hl=en&ct=clnk&cd=1&gl=us
2-3http://www.fda.gov/cdrh/comp/designgd.pdf
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. To learn more about quality system management solutions or automated compliance with 21 CFR Part 820, please feel free to contact a MasterControl representative.
From cutting across the wrong lines in kindergarten to appearing too anxious on a first date; everybody knows that first impressions and first endeavors really count.
For medical device companies the principle of starting out right is extremely essential because medical device companies literally hold human lives in their hands. So how can med device companies always start out right? The answer is by controlling their quality systems and especially, their design processes.
Why Design?
You might wonder why design would be the most important aspect (or at least the most crucially determinate) aspect of quality system management for a medical device company. Even the FDA in past decades paid less attention to design concerns and focused on manufacturing. That changed however when serious errors began to occur and an FDA recall study found that "44% of medical device recalls [were] due to design problems,"1 which makes it abundantly clear that design mishaps are not only a headache for the FDA but are primarily detrimental to the medical device companies themselves.
Design Control Guidance for Medical Device Manufacturers
Since the FDA´s discovery regarding the important nature of design, the FDA has created regulations as aspects of the FDA Quality System regulations (21 CFR Part 820). These design-focused quality system regulations can also be compared to those standards documented in ISO 9001 quality system related content.
To make these design-related regulations clear and understandable for a variety of design control professionals, the FDA has released a Design Control Guidance for Medical Device Manufacturers. The guidance contains a variety of information regarding development planning, design input, design output, design review design verification, etc.
Each of these topics merit some discussion but the remainder of this article will focus on a topic that is likely to influence all aspects of design control and in turn the entire quality system.
Quality System: Design Related Organizational Responsibilities
The organization responsibilities for quality system design requirements can be found in the QS regulation documentation in the management section. This aspect of the regulations, like most life science regulation facets, is flexible to every company´s unique circumstances. According to the design guidance, "The management responsibility section of the quality system requirements requires management to establish a quality policy and implement an organizational structure to ensure quality."2 This of course means that it is the medical device company´s duty to ensure that organizational responsibilities are well documented and that training related to organization responsibilities is very clear. Some companies may even want to participate in quarterly trainings to keep development plans "on the brain."
All of these quality system tips may sound simple to accomplish but it isn´t enough to simply define and document those who have organizational responsibilities and then follow those tasks with training courses. Instead, interface events, interrelationships between responsible parties/individuals as well as their authorities and responsibilities need to be "defined, documented, coordinated, and controlled." According to the FDA´s design guidance:
"This might be the case, for example, if a multidisciplinary product development team is assembled for a specific project, or if the team includes suppliers, contract manufacturers, users, outside consultants, or independent auditors."3
Conclusion
It is essential that representatives from medical device companies not only be familiar with organizational responsibilities regarding design control but that they also familiarize themselves with the Part 820 quality system regulations in general.
1 http://209.85.173.104/search?q=cache:DUvhKcooGCEJ:www.cs.umd.edu/hcil/about/events/open-house-2004/SOH04Carstensen.ppt+%2244%25+of+medical+device+recalls+due%22&hl=en&ct=clnk&cd=1&gl=us
2-3http://www.fda.gov/cdrh/comp/designgd.pdf
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. To learn more about quality system management solutions or automated compliance with 21 CFR Part 820, please feel free to contact a MasterControl representative.