What is BS EN ISO 13485:2013 ?

What is BS EN ISO 13485:2013?

BS EN ISO 13485:2013 is a standard published by the British Standards Institution (BSI) that outlines a framework for the management of medical device design and development. This standard is designed to ensure that medical devices are developed and manufactured in a systematic and reliable manner, minimizing the risk of harm to patients and others.

The purpose of BS EN ISO 13485:2013The main purpose of BS EN ISO 13485:2013 is to establish a comprehensive guide for the entire medical device development process, from concept through to final product validation. It provides a structured approach to the management of medical device design and development, including the identification and management of risks associated with the development process.

Key Requirements of BS EN ISO 13485:2013

Systematic approach to medical device design and development

Identification and management of risks throughout the development process

Documentation of medical device design and development

Integration of design and development activities into the overall medical device development process

Compliance with relevant regulations and guidelines

Documentation of the design and development process, including the results of formal testing and validation

Quality management system for medical device design and development

Documentation of the design and development process for medical devices that are intended for use in the home or in remote settings.