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...
ISO 13485 Contamination Control Procedure & Product Cleanliness
Updated: October 24, 2023. By maintaining the ISO 13485 contamination control procedure and strict control measures, manufacturers can minimize the...
Updated: October 24, 2023. By maintaining the ISO 13485 contamination control procedure and strict control measures, manufacturers can minimize the potential for contamination and uphold the quality and reliability of their medical devices. In this...
How to use ISO 13485:2016 to manage implantable medical devices
A medical or surgical device is meant to interact with the human body during surgery, while some devices are intended...
A medical or surgical device is meant to interact with the human body during surgery, while some devices are intended to stay in a human body for an extended period of time. Devices that interact...
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...
