As we’re preparing for Thanksgiving, we’ve been reflecting a lot on what we are grateful for this year. It would be pretty cliché to say we’re thankful for our customers, but we are. Our customers are the reason we do what we do, and we spend every day working on making your experience using Beacon the best we possibly can.
Today, though, we want to focus on one particular group we don’t think receives enough gratitude: the Quality Department.
The quality department in a medical device company plays a critical role in ensuring products meet regulatory requirements, safety standards, and customer expectations. This often means managing some uncomfortable situations, such as product issues or failures.
They are tasked with handling any quality issue or change though a large quality system, mountains of paperwork, and a broad cross-functional group of stakeholders in order to make sure patients receive the best quality of care from the company.
This job can be thankless, and is not often thought of as a revenue generating department. But ask yourself: where would your company be without your quality department?
While sales and distributors are not typically interacting directly with the quality department, that doesn’t mean that they do not impact each other. So we decided to talk to some Quality managers to get an idea of how the field team might make their lives easier. Here’s what we heard:
- Unique Device Identifiers: Medical device manufacturers are required by the FDA to maintain traceability of UDIs all the way to the point of use. This is no easy task, but it requires attention to detail throughout the sales process. So, while it may be an adjustment from how they’ve normally done things, making sure the UDI is on the critical documents and is communicated to the provider is one way Quality managers say the field can help them stay in compliance.
- Data integrity: Making sure that sales orders and other documents are written legibly and include all correct information ensures that all items are accounted for and the company has traceability of what devices were used with which patient. The information that is collected during the sales process is often codified in the QMS, making it a regulatory imperative.
- Post Market Surveillance: Product feedback is important to improving future generations of products as well as helping to mitigate any potential product issues. It is also a regulatory requirement of a medical device company’s quality system, especially when they must create a Corrective Action. PMS is a critical part of any product investigation, so the ability of the field team to obtain this information promptly and effectively helps the Quality department meet this regulatory and operational need.
Quality is a critical part of any medical device company. They make sure the company is fully compliant with all regulations, while also ensuring that all products meet quality standards.
The quality role is not an easy one, so it’s important for teammates to do what they can to ensure all regulatory and quality requirements are met. This can certainly be done operationally, but consider what tools your field team is using which might be able to handle some of these requirements automatically.
At ConnectSx, quality is a central theme of our products. We make the traceability of a medical device seamless through its lifecycle and maintain an enduring source of truth for all critical data to serve as an operational beacon 😉 for Quality when they need to draw on it.
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