Integrate QA & Development

The fierce and intense cut-throat market requires companies to release their products to the market as quickly as possible. In this fast-paced environment, the timely release of a high-quality product depends upon an effective and efficient collaboration of the QA and development teams. This is not always easy as both teams contribute to different aspects of the project. A balance must be struck between swift development of innovative products involving creative solutions, effective design, and rapid testing with quality assurance that often slows down development. International standards governing different aspects of the medical device combined with rigorous, comprehensive documentation of the product, its manufacturing processes, and its usage will help mitigate conflicting interests.

Emphasizing the joint purpose of both teams will lead to the pursuit of a common goal: a solid high-quality, innovative product. An effective integration of the QA and development efforts requires attention particularly in the following aspects:

• Communication should flow in an open channel. It is essential that both teams advocate consistent communication to ensure that all stakeholders are aware of project details and overall progress.
• Knowledge must be shared. A regular exchange of technical, regulatory, and other information between both teams is crucial for the success of their common goal.
• Conflicts ought to be resolved as they occur. Teams should be familiarized with a conflict resolution process and encouraged to apply it in order to facilitate adequate solutions that serve the different aspects of the joint goal.
• Respect should be synonymous with organizational culture. A culture of mutual respect goes a long way in promoting confidence and motivation, two essential components for the integration of QA and development efforts.

Li-Med has vast experience in establishing and maintaining a Quality Assurance system for medical device companies throughout their lifecycle. The process that we establish maintains the Plan-Do-Check-Act (PDCA) cycle and ensures the integration of the design and development process with Quality Assurance Management.