Depending on the medical device type you can assume who are potential users of the same. After you define that, you will easier understand this chapter of ISO 13485.


Determination of the requirements related to the product

There is a standardized method to identify the inputs that supposed to form and determine the device. As a medical device company, you can precisely determine what the product specifications are and evaluate whether it can meet these specifications. Including the customer’s expectations of the medical device, it’s easier to come to the definition of the end product.

Of course, everyone is aware achieving all customers' requirements is almost impossible, but some areas don’t leave room for compromise – such as regulatory and safety requirements.

The organization should develop the method of capturing all inputs and distributing them to appropriate business units. There are no standard methods for such, but it may include: customer files, checklists, order forms, etc.


Review of requirements

ISO 13485 always points out how important is for medical device companies to keep to a high standard when it comes to the products and services they offer to customers. Very important is to clarify and understand customer’s requirements, translate them into organizational terms, and ensure the organization can meet them.

By reviewing is meant to filter requirements through risk management, product specifications, regulation, and functionality. The point is that the review assures the company can commit to supply the product to the customer. 

It’s possible that customers might change their minds and needs, and the ISO 13485 Standard is aware of that. Because of this, a medical device company must maintain control over the realization and effectiveness of the requirements. Customer requirements have to be reviewed on several viewpoints that might affect the medical device.



ISO 13485 clearly states that every medical device company has to have a documented system for communication with customers. Also, the way how you will communicate with your customer depends on the type of your device. The reason for communication can be required product information, inquiries, contracts or order handling, or customer feedback that includes complaints as well.

Be aware, that you have to inform the customer about all updates, changes, and improvements of the medical device. Also, to maintain the effectiveness of the communication channels, you have to define the roles for each type of customer communication. Each role will be responsible for managing the communication channel according to the definition related to the specific case.

The customers’ feedback provides you an objective point of view on whether your medical device company supplied the device according to the requirements. It's advantageous to get an early warning about potential quality problems. This process effectively creates inputs for improvement and initiates the necessary corrective and preventive actions.







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