ISO 13485
Medical Devices Quality Management System
Service
Certiquality provides companies operating in the medical devices sector with certification services for quality management systems according to the ISO 13485 standard.
Companies producing Medical Devices can also easily integrate the Quality System compliant with the ISO 13485 standard, with the additional requirements of the ISO 9001 standard, regarding the customer satisfaction and the continuous improvement of organizational performance and processes.
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Context
In order to place a medical device on the market according to Regulation (EU) 2017/745 or Regulation (EU) 2017/746, the Manufacturer must develop and implement a comprehensive quality management system or production quality assurance/guarantee system based on the risk class of such product.
The ISO 13485 standard specifies the requirements for a quality management system that can be used by an organization in the design, development, production, installation and maintenance of medical devices, as well as in the design, development and the provision of related services.
The ISO 13485 standard specifies the requirements for a quality management system that can be used by an organization in the design, development, production, installation and maintenance of medical devices, as well as in the design, development and the provision of related services.
Recipients
This service is intended for any company: • manufacturing or placing on the market medical devices, in-vitro diagnostic medical devices • designing, manufacturing or testing devices or components or sub-assemblies of such devices for the benefit of third parties • designing, developing or providing services related to medical devices, such as for example sterilization, distribution, installation and maintenance of medical devices, surface finishing or packaging.
Benefits
To demonstrate the ability to supply medical devices and provide related services that meet customer requirements and comply with the applicable regulatory requirements.
To facilitate any qualification process with a manufacturer wishing to outsource, partially or totally, the production activities of a medical device.
The Certification Process
- an optional preliminary audit to assess the condition of the company’s management system against the requirements of the ISO 13485 standard;
- a gap analysis will identify the system’s strengths and potential areas for improvement;
- a certification audit, with the aim of assessing the compliance of the management system to the requirements of ISO 13485, through a documentary analysis and on-site findings;
- issuance of the certificate of conformity;
- annual surveillance audits and triennial renewal audits.
ISO 13485 audits can be combined with audits against the ISO 9001 standard or the requirements of EU Directive 93/42/EEC.
Training
Certiquality can integrate classroom training to its activities, which can also be dispensed on your company’s premises. Courses cover various topics such as:
• Regulation (EU) 2017/745;
• Risk Management in the production of Medical Devices according to the ISO 14971 Standard;
• the ISO 13485 Standard (Quality System for Medical Devices);
• Clinical Evaluation of Medical Devices.
• Regulation (EU) 2017/745;
• Risk Management in the production of Medical Devices according to the ISO 14971 Standard;
• the ISO 13485 Standard (Quality System for Medical Devices);
• Clinical Evaluation of Medical Devices.