How to manage design and development of medical devices according to ISO 13485:2016
Waqas Imam
The design and development process for medical devices is not as simple as in other manufacturing or service industries. Design...
The design and development process for medical devices is not as simple as in other manufacturing or service industries. Design and development for medical devices has to deal with relevant regulations, product safety, and risk...
Infrastructure requirements according to ISO 13485:2016
Updated: October 9, 2023. The manufacturing, design, or supply of any product or service needs an infrastructure – without infrastructure,...
Updated: October 9, 2023. The manufacturing, design, or supply of any product or service needs an infrastructure – without infrastructure, no firm can carry out its activities. Infrastructure includes buildings, workspaces, utilities, process equipment, instruments,...
How to meet ISO 13485:2016 requirements for medical device files
The requirements for medical device files in ISO 13485:2016 are an endeavor by the ISO Technical Committee (TC 210) to...
The requirements for medical device files in ISO 13485:2016 are an endeavor by the ISO Technical Committee (TC 210) to create consistent operations for medical device manufacturers, and also to make their Quality Management Systems...
How to manage the medical device sterilization process according to ISO 13485:2016
Sterilizing medical devices is of vital significance in the medical sector. Even so, at various places in the world, surgical...
Sterilizing medical devices is of vital significance in the medical sector. Even so, at various places in the world, surgical devices are not properly sterilized. As a result, many patients die, while many more are...
ISO 13485:2016 nonconforming product – How to approach the post-delivery actions
Medical instruments are critical healthcare and life-saving devices that are meant for surgeries, implantation, and other medical objectives. Many medical...
Medical instruments are critical healthcare and life-saving devices that are meant for surgeries, implantation, and other medical objectives. Many medical instruments are reused after they have gone through the sterilization process. Any non-conformity in a...
Mandatory documents required by ISO 13485
Strahinja Stojanovic
Updated: September 19, 2023. The new ISO 13485 is based on ISO 9001:2008, which means that the ISO 13485 2016...
Updated: September 19, 2023. The new ISO 13485 is based on ISO 9001:2008, which means that the ISO 13485 2016 documentation requirements are based on the requirements of the previous version of ISO 9001, with...
