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...
How to get ISO 13485 certified?
If you are using ISO 13485:2016 to create a Quality Management System (QMS) for your medical device company, you will...
If you are using ISO 13485:2016 to create a Quality Management System (QMS) for your medical device company, you will likely consider certification against this standard. Certification by an independent third-party registrar is a good...
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...
Which ISO 13485 course should I choose?
Updated: October 29, 2026. A quality manager preparing for ISO 13485 certification needs different training than a production employee who...
Updated: October 29, 2026. A quality manager preparing for ISO 13485 certification needs different training than a production employee who only needs awareness of medical device quality requirements. Likewise, someone who wants to become an...
