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What are the post-market surveillance requirements in the MDR?
For each medical device that is to be sold in the European Union market, the manufacturer must prepare the technical...
For each medical device that is to be sold in the European Union market, the manufacturer must prepare the technical documentation to demonstrate that the device was designed and manufactured in accordance with all applicable...
Medical device classification according to the EU MDR
Updated: September 22, 2023. With the new Medical Device Regulation, it is important for medical device manufacturers to understand how...
Updated: September 22, 2023. With the new Medical Device Regulation, it is important for medical device manufacturers to understand how the new classification rules apply to the different types of medical devices. These new EU...
How to write clinical evaluation reports under the EU MDR
No matter what medical device you make, if you wish to sell within the European Economic Area, you will need...
No matter what medical device you make, if you wish to sell within the European Economic Area, you will need to meet the requirements of the Medical Device Regulation (MDR), and in particular the requirements...
Comparison of the EU MDR and IVDR regulations
Updated: September 19, 2023. The need for new regulations for medical devices and in vitro medical devices was driven by...
Updated: September 19, 2023. The need for new regulations for medical devices and in vitro medical devices was driven by changes in the industry and the need to improve patient safety. The previous regulations were...
ISO 13485 Quality Policy
Updated: October 9, 2023. When implementing a Quality Management System (QMS) for your medical device manufacturing organization, you will find...
Updated: October 9, 2023. When implementing a Quality Management System (QMS) for your medical device manufacturing organization, you will find that one of the first things you need to write according to ISO 13485:2016 is...
What are the EU MDR technical documentation structure and requirements?
What are the EU MDR technical documentation structure and requirements? ISO 13485 TEMPLATES ISO 13485 COURSES FREE MATERIALS Kristina Zvonar...
What are the EU MDR technical documentation structure and requirements? ISO 13485 TEMPLATES ISO 13485 COURSES FREE MATERIALS Kristina Zvonar Brkic TABLE OF CONTENTS What is technical documentation? What is the structure of the technical...