ISO 13485:2016 – Mandatory documents list

ISO 13485:2016

The new ISO 13485 is revised on the structure of ISO 9001:2008, which concludes that the requirements for documentation are founded on the needs of the earlier version of ISO 9001, with the inclusion of additional documents related to the medical and surgical devices industry. So, let’s have the list below which are the mandatory documents, but youRead More

FDA 21 CFR Part 820 Versus ISO 13485 – Relationship Comparison

Relationship & Scope

Medical devices companies can voluntarily adopt ISO 13485:2016 standard for Quality Management Systems of medical device manufacturers and suppliers.  It is utilized globally for creating and maintaining the system that satisfies the requirements of the market of medical devices. One of the core reasons that ISO 13485 was revised in 2016 is the configuration ofRead More

ISO 13485:2016 Quality management systems & Requirements for regulatory purposes of Medical devices

ISO 13485:2016 demonstrates needs for a quality management system where a company requires to show its capability to supply medical instruments and concerning services that regularly meet customer satisfaction and related regulatory concerns. Such companies can be a part of supply chain in one or more phases of the product cycle for example in designRead More