What are EU harmonized standards?
Kristina Zvonar Brkic
If you are a manufacturer in the European Union, it can be difficult to try to align the different standards...
If you are a manufacturer in the European Union, it can be difficult to try to align the different standards in the various countries. As it turns out, the EU has released a list of...
ISO enabled free access to ISO 13485 and other medical device and protective clothing standards
Liza Horielikova
To support the initiatives dealing with the impact of COVID-19, the International Organization for Standardization (ISO) has made some of...
To support the initiatives dealing with the impact of COVID-19, the International Organization for Standardization (ISO) has made some of its standards supporting the biological evaluation of medical devices and protective clothing used in health...
MDR compliance, and how ISO 13485 can help with it
Updated: October 26, 2023. MDR compliance refers to adherence to the European Union Medical Device Regulation 2017/745 (EU MDR 2017/745)...
Updated: October 26, 2023. MDR compliance refers to adherence to the European Union Medical Device Regulation 2017/745 (EU MDR 2017/745) by medical device manufacturers. It involves meeting the necessary regulations and requirements to ensure the...
How to perform ISO 13485 training
Implementing a Quality Management System (QMS) for your medical device manufacturing company using the requirements of the ISO 13485:2016 standard...
Implementing a Quality Management System (QMS) for your medical device manufacturing company using the requirements of the ISO 13485:2016 standard can be difficult. Along with figuring out what needs to be done within your organization...
How to choose a consultant for ISO 13485 implementation
Chany Runnels
If your company has decided to implement the ISO 13485 standard, you might be considering bringing in a consultant to assist...
If your company has decided to implement the ISO 13485 standard, you might be considering bringing in a consultant to assist with the implementation process. The wise selection of an ISO 13485 consultant is one solution...
Calibration requirements in ISO 13485
Anita Joshi
Updated: August 28, 2023 Manufacturing medical devices is a highly complex process, and calibration requirements according to ISO 13485, Clause...
Updated: August 28, 2023 Manufacturing medical devices is a highly complex process, and calibration requirements according to ISO 13485, Clause 7.6 (Control of monitoring and measuring equipment), mean high precision and close monitoring. Accuracy of...
