Quality System Management for Medical Devices
Quality System management is an operation where a medical device manufacturer or supplier needs to provide medical devices that consistently meet customer requirements and regulatory requirements. The ISO 13485:2003 specifies these requirements in more detail. Medical devices manufactured without a (correct) internal quality system are denied at the border and can’t legally enter the desired market. For this reason national regulatory schemes require manufacturers and suppliers of medical devices to create an independently verified and audited, internal quality management system.
Importance of a verified quality management system
In the European Union, the requirements of ISO 13485 have been harmonized with the essential requirements of the:
- Medical Device Directive (93/42/EEC),
- Directive for In Vitro Diagnostic Medical Devices (98/79/EC),
- Directive for Active Implantable Medical Devices (90/385/EEC).
An ISO 13485 Certification provides a presumption of conformity with the essential requirements of these important directives.
The US (The Food and Drug Administration) and Canada (Health Canada) also require medical device manufacturers to have their quality management system certified to ISO 13485.
ISO 13845 is going under revision
The ISO 13845 is currently being revised by the International Standard Organization and is expected to be published this year (2016).
The most important changes in the revision are:
- The application of a risk-based approach in the development of most aspects of a quality management system.
- Validation of the application of computer software used in the quality management system (currently only for production)
- Establishment of Medical Device File(s)
- New requirements for complaint handling procedures
- Validation of processes for sterile barrier systems as well as sterilisation
- Responsibilities of the manufacturer
How can we help you?
Our experts at Certification Experts are highly experienced in supporting medical device manufacturers in checking their quality system. We provide them with constructive feedback and support related to medical device quality management system. For more information, advice or support please contact us. There are 4 methods to contact us:
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