When a device has serious complaints, what is the regulatory professional's first contact?

When a device has serious complaints, the regulatory professional's first contact is typically with the quality assurance department. This is because quality assurance is responsible for monitoring the compliance and performance of the device. They play a critical role in assessing any potential risks associated with the complaints, as well as investigating the root cause of the issues reported.

Quality assurance teams are well-equipped to handle product complaints since they oversee the quality systems that ensure compliance with regulatory standards. They can quickly analyze the situation, initiate investigations, and determine whether corrective actions are necessary. Engaging with quality assurance allows for an informed and standardized approach to dealing with serious complaints, ensuring that all regulatory requirements are being met and that patient safety is prioritized.

On the other hand, while the manufacturing department, sales team, and legal department are also important in their respective roles, they do not typically provide the immediate oversight needed for assessing the quality and safety of a device in response to complaints. The manufacturing department may eventually need to be informed if the issue relates to the production process, the sales team may need to communicate with customers, and the legal department may become involved if there are potential liabilities. However, the initial and most relevant contact for serious complaints lies with quality assurance.