Medical Device Quality: The Poly Implant Protheses (PIP) breast implant scandal was one of the most notorious patient protection failures to have occurred in clinical research. The implants were made from a cheaper, industrial-grade silicone that was not approved for medical use and ruptured easily, leading to scarring and inflammation. The choice of a poor-quality material was life changing for these patients and it also led to significant regulatory change.
As a quality manager, you are responsible for establishing a company’s quality procedures and standards. You will also make sure that all production processes meet both national and international regulatory standards. When it comes to medical devices, the role of a quality professional involves developing and managing a product’s quality management system (QMS) and driving forward the manufacturer’s regulatory strategy.
In medical device companies, the quality manager is therefore responsible for overseeing compliance with the U.S. Food and Drug Agency (FDA), EU Medical Device Regulation (MDR) and other relevant frameworks. This means providing regulatory support for projects, assisting with product labelling and supporting manufacturers with their applications to the notified body (NB).
Introduction to design controls
Design controls are a set of procedures that manufacturers build into the design and development (D&D) process to ensure the design translates into a device that is appropriate for its intended use. Design controls link the user requirements to the device’s design inputs and outputs. This can help quality managers carry out vital tasks, like investigating complaints, managing technical files like the Design History File (DHF), and coordinating post-market surveillance (PMS) activities before the device is taken to an NB.
When reviewing medical device non-conformance, you will expect to find design controls in place for Class II and Class III devices like endoscopes, because these are deemed to be a higher risk. You will rarely find these controls in Class I devices unless they are being automated with software.
Understanding user requirements
The responsibility of a quality manager commonly includes investigating complaints that have been made about the device. From a quality perspective, complaints highlight any historical faults, and it can help you to determine whether the product is now at a standard where an application can be submitted to an NB. Manufacturers will use the design controls to document these complaints alongside the original user requirements. This can help them demonstrate how patient needs have been built into the final design.
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