BS EN ISO 13485 - Medical Devices Quality Management

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QUALITY MANAGEMENT FOR MEDICAL DEVICES ISO 13485:2012

What is ISO 13485?

ISO 13485 is a standard for identifying the control of a quality management system, which has been developed specifically for medical devices. It is an international standard subscribed to by the UK, USA, Japan, Europe and most of the rest of the World.

Its purpose is to demonstrate an organisation's commitment to meeting customer requirements and work towards customer satisfaction through continuous improvement and to error prevention.

ISO 13485 supersedes previous medical Quality Assurance Standards, BS EN EN46000 and the previous issue of ISO 13485:2003.

The latest version is ISO13485:2003 but in the EU there is a newer version ISO13485:2012 which holds a number of appendices to guide businesses into cross references between the relevant Medical Directive and the Standard.

ISO13485 helps an organisation introduce the tools to implement and maintain product surveillance programmes, that will ultimately translate into good product and service quality.

The requirements are for a fully documented set of procedures linked to the appropriate European Directive, etc.

The standard contains clauses identifying areas of any business that the Company must address when developing a management system to demonstrate regulatory compliance for medical devices

ISO13485 implementation is an investment into the future. Its disciplines create a useful structure from which continuous improvement programs can be implemented and progressed. The monies spent on implementing and maintaining the disciplines of ISO13485 are recovered when the organisation uses the standard as intended...a tool to help a business move forward. The full benefits of introducing such a system can take time to be fully realised.