How to use ISO 13485 to fulfill FDA regulatory classes for medical devices
Waqas Imam
As a medical device manufacturer, even if you don’t have the ISO 13485 certification, you have to comply with the applicable...
As a medical device manufacturer, even if you don’t have the ISO 13485 certification, you have to comply with the applicable regulatory requirements to market your products. Compliance with regulatory requirements is given equal importance in...
Using ISO 13485 to manage process validation in the medical device manufacturing industry
During manufacturing, a medical device is either in the final stage of manufacturing (finished goods) or in the semi-finished goods...
During manufacturing, a medical device is either in the final stage of manufacturing (finished goods) or in the semi-finished goods stage. Industrial processes in medical device manufacturing facilities convert raw materials into semi-finished materials, and...
How to manage medical device recalls and advisory notices according to ISO 13485
Updated: September 22, 2023. A recall, along with necessary advisory notices, is an important but reactive approach that is used...
Updated: September 22, 2023. A recall, along with necessary advisory notices, is an important but reactive approach that is used by medical device manufacturers to remove a medical device from the market due to regulatory...
How to manage design and development of medical devices according to ISO 13485:2016
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...
