Trends in 4.0 quality of the medical device industry (Part 4)

Closed-cap CAPA* processes help quality teams identify, analyze, and solve quality issues faster.

*CAPA – Corrective and preventive action – Corrective and preventive action including improvements to an organization’s processes taken to eliminate the cause of nonconformities or other undesirable situations.

For example, Pulse Bioscatics has implemented a closed quality system throughout its organization. All team members can collaborate to work on the latest product definition and latest quality profile with product-centric QMS. With streamlined CAPA processes, Pulse Bioscatics is able to address urgent corrective actions quickly with better audits.

Kinsa provides the first doctor-recommended smart thermometer by the U.S. Food and Drug Administration (FDA). They deployed a product-centric product portfolio to support the company’s first connected device design. The adoption of Quality 4.0 technologies has helped Kinsa revolutionize the way healthcare can be simulated in the IoT universe through connected technologies to streamline product development, improve Quality management and shortening time to solve customer problems.

Keep up with Quality 4.0

The march to provide smarter devices is moving forward at full speed. Both large, established medical device companies and smaller innovators are racing to improve health by connecting people and data with newer technologies like IoT, AR and robots to Bring better results to patients around the globe.

Advances made with Industry 4.0 have helped promote Quality 4.0 technologies and strategies to improve quality compliance. The ability to streamline quality processes and develop complex products is critical to competing in today’s global economy. Not only have we developed products virtually with distribution groups, we now have the ability to heal and perform surgeries in which doctors and patients are separated by multiple time zones. Smart robots and augmented reality devices.

Quality Trends 4.0 requires smarter, connected strategies to ensure your company is not left behind. So, consider your goals and realities to create and deliver complex products that meet FDA and ISO regulations. Make sure you can create a fully monitorable environment, minimize risks and ensure the quality of business at your organization.

Productivity and Quality Office