ISO 13485: A Comprehensive Guide for Medical Devices
One large sector of the economy is the medical industry. To help individuals combat unusual health conditions and live comfortable, simple lives, the medical industry sector is the next large rising market globally.
Quality and safety are paramount when it comes to medical devices. To ensure that their products fulfil the legal and quality requirements, manufacturers and suppliers adhere to severe restrictions. Medical device QMS (quality management system) is one area covered by the ISO 13485 standard.