ISO 13485 – Medical Devices adapts the ISO 9001 process model for a regulated medical device manufacturing environment. It was written to support medical device manufacturers in developing quality management systems that establish and maintain the effectiveness of their processes. This ensures consistency in the design, development, production, installation and delivery of safe medical devices in your proposal.
Thus, through the implementation of the ISO 13485 standard, it is possible to configure a quality management system that includes:
- consistent design;
- product development;
- production;
- storage and distribution;
- installation and maintenance (if any);
- deactivation or disposal;
- technical support.
Related patterns:
ISO 14971 – Applying risk management to medical devices. This standard specifies a procedure for manufacturers to identify hazards associated with medical devices and accessories and how to estimate and assess, control and monitor identified risks, as well as the effectiveness of control.
ISO/TR 80002-2: 2017 Medical Device Software – Software validation for medical device quality systems. This standard applies to any software used in the design, testing, component acceptance, manufacturing, labeling, packaging, distribution and handling of device claims, or to automate any other aspect of a medical device quality system as described in ISO 13485. .
Key benefits of implementing ISO 13485
Companies that have this certification, express their commitment to quality, both to customers and to regulatory bodies.
- Increase access to global markets with certification
- Describes how to review and improve processes across the organization
- Increases efficiency and monitors supplier performance
- Demonstrates that you produce safer and more effective medical devices
- Meets regulatory requirements and customer expectations
In order for the quality management system to function in accordance with the requirements of the ISO 13485 standard, it is essential that the company carry out periodic audits.
ISO 13485 applies to medical device manufacturers and organizations that support those manufacturers. It upholds manufacturers’ duty to ensure that devices consistently meet customer and applicable regulatory requirements.