Building a strong team is the foundation of any successful business. At Blur, quality and operations working together is a foundational part of the team atmosphere. Our goal is to keep our teams engaged in the entire process by including them in the development as well as any changes in procedural requirements. This allows the process to work with the team rather than against them. As Noah Muse, the Director of Quality at Blur states, “We have the same goal and we’re working together to get there.” 

Quality and Operations

“At Blur, it’s believed that quality and operations need to work closely together,” says Noah, “Everyone has the responsibility of quality in the organization as well as the desire to meet customer goals and to work together to achieve them.” Although our quality system may have a lot of standard operating procedures (SOPs) in place, we ensure that there are flexible pieces within them. This gives each of our teams room to maneuver while maintaining the high standards they have set for themselves.

Noah holds an ongoing meeting called Cooperations where quality and operations come together to develop processes and SOPs. The unique part about this meeting is that they don’t design these procedures in a vacuum: “As we’re developing or making changes to some of the procedural requirements, we’ll engage the team that works in that area and that allows the process to kind of work with the team rather than against them,” Noah says. 

The regulatory bodies like the FDA and the ISO standards provide general QMS standards, but there are a lot of ways to incorporate the requirements and handle customer needs.

Why such high standards?

In the medical device industry, companies must adhere to strict QMS standards set by regulatory bodies such as the FDA (Food and Drug Administration) and ISO (International Organization for Standardization).

The FDA and ISO have established QMS standards to ensure medical devices are safe and effective for use. These standards outline the requirements for developing, manufacturing, and distributing medical devices. In the US, the FDA’s QMS standards are outlined in the Code of Federal Regulations (CFR) Title 21. This includes requirements for design control, production and process control, and corrective and preventive actions.

Standards for Medical Device Manufacturers

Similarly, the ISO has developed a set of international standards called ISO 13485 for medical device manufacturers. This standard outlines the requirements for implementing a QMS and ensuring that medical devices consistently meet customer and regulatory requirements.

Adhering to QMS standards is crucial for medical device manufacturers to ensure the safety and efficacy of their products. Noncompliance can result in legal consequences, recalls, and reputational damage. Therefore, medical device manufacturers must implement robust QMS systems and regularly monitor and improve them to maintain compliance with the standards set by regulatory bodies.

If you’re looking to improve your quality and operations, reach out to Blur and let us know where you are in your process. With our team-oriented approach and vast experience, we’ll will work with you to achieve your goals and exceed your expectations.