Everything you might want to know about ISO 13485

Medical devices are supposed to be the most reliable devices on Earth – without them, it would be impossible to carry out procedures and help people get better. In order to make sure that everything is how it’s supposed to be, companies that provide medical devices and related services need to constantly meet customer and regulatory requirements. As such, most of them decide to comply with ISO 13485 and get a certificate proving that their quality management system is up to date and their products meet all the important standards.

ISO 13485 – what is it?

ISO 13485 and specifically its 2016 version specifies requirements for a quality management system for medical device and software providers. With such system, they are more than certain to meet all the regulatory and customer requirements and provide medical devices that are safe to use and pose no threat to human life. ISO 13485 is particularly relevant for companies involved in one or more stages of the device’s lifecycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development, or provision of associated activities such as technical support.

medical device

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How to implement ISO 13485?

Implementation of ISO 13485 standards is not an easy task and should be approached as a project that the entire company takes on. It is necessary to note that both the managers and the employees must be made aware of why it is important to implement ISO requirements and why such strict rules shouldn’t be seen as an obstacle, but rather an advantage that helps the company to stay relevant and provide the best services they are able to. ISO 13485 implementation usually starts with an audit assessing current quality management system and all practices just to make note of how much needs to be improved and which areas are in need of improvements the most. By doing this, the company is made aware of all their weaknesses and can then proceed to make further steps including thorough risk assessment, implementation of new strategies and practices, constant testing and improvement and monitoring the whole process. To get certified you need to comply to the ISO 13485 as a whole and meet all the standards mentioned there. After all, the QMS was designed by an international systematization organization and it’s been done with the safety of the devices in mind.