Determination of requirements related to the product according to ISO 13485

Customer related processes iso 13485

It’s on medical device company to identify all requirements of a product, a medical device.  This needs to include those requirements like

  • customer specifications
  • unspecified but necessary for the product to work properly (established by legal and regulatory authorities)
  • estimated as necessary by the organization

The main purpose of Customer-related processes, as specified in the ISO 13485:2016 standard, is to ensure that the organizations will fulfill a high quality when it comes to the products and customer services. It is a way of establishing the focus of the organization and its product on the customer.

Medical device requirements can be seen as a collection of inputs or data. They need to set the criteria for their validation. To accurately identify the product’s requirements, the organization needs to develop a way to gather and review these inputs.

It’s necessary to check the probability if the medical device will be by customer expectations and/or requirements. MedDev company will have to review all of them, which includes regulatory, organizational, safety, and customer requirements. The point is to aim for everything to be clear, documented, and distributed accordingly.

There is a standardized method to identify the inputs that supposed to form and determine the device. The company can precisely determine what the product specifications are and evaluate whether it can meet these specifications. This evaluation requires collaboration with production, design, and development, etc.

For this method is intended to cover the following stages:

  • Gathering the regulatory or other product’s requirements
  • Collaborating with the customer – defined in the chapter Customer communication
  • Estimating whether the organization can deliver the customer with a suitable product
  • Accepting and gathering the customer requirements related to the product
  • Translating and processing requirements into the required realization activities
  • Delivering the requirements between the different relevant organizational units

Achieving all of the customers’ requirements is almost impossible. In some areas and product scopes, there isn’t a lot of space for compromise, such as regulatory and safety requirements. The organization should define a method for:

  • Capturing all the inputs that may serve as requirements
  • Fully apprehending these requirements
  • Assurance that all relevant documents are provided
  • Distributing all the requirements to the appropriate organization units

It’s not necessary to document the method since isn’t required from the standard, although, the auditor will request evidence to prove that the method is defined and implemented.
The medical device company has to plan and present the main tools that will help in meeting the requirements. It is intended to include the following:

  • Management system
  • Document characterization
  • Checklists
  • Order forms
  • Customer files
  • Summary report of research

Customer Requirements

Including the customer’s expectations of medical devices, the company will define product requirements. Through defined communication channels, the customers are formally introducing their needs. Types of customers’ requirements can include:

  • Storage and protection
  • Standard certification
  • Assurance
  • Prices and terms of payment
  • Service and maintenance
  • Product-related requirements (quality, safety, intended use, etc.)
  • Packaging and identification

Medical device company is expected to find their way or method of receiving, capturing, and reviewing the customer’s requirements. There are several ways to do it:

  • Surveys
  • Documentation
  • Request for proposal
  • Diagrams and drawings
  • Technical specifications

Additional requirements

The company has to incorporate and evaluate all other realization requirements that aren’t customer’s concerns but are crucial to the realization processes. They include:

  • Necessary processes
  • Qualifications, knowledge or skills
  • Material or components
  • Activities for the disposal of materials
  • Workshops, production resources, and workstations

Additional requirements not Stated by the Customer

Some areas aren’t covered or taken into account by the customer, such as:

  • The operating environment
  • Interfacing with other products or equipment
  • Transportability
  • Service and maintenance

Regulatory requirements

These requirements can include applicable safety, environmental, and government regulations. They may apply to the storage, recycling, handling, elimination, or disposal of products or materials.

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