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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 documentation to demonstrate that the device was designed and manufactured in accordance with all applicable Medical Device Regulation (MDR) requirements. What is post-market surveillance in the MDR? Post-market surveillance is a process of proactively collecting ...Read more

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 the new classification rules apply to the different types of medical devices. These new EU MDR classification rules can be a bit confusing, and because they affect what you have to do before selling your ...Read more

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 to meet the requirements of the Medical Device Regulation (MDR), and in particular the requirements for clinical evaluations of your medical device. Elements of the MDR clinical evaluation report Summary Scope of clinical evaluation Clinical ...Read more

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 changes in the industry and the need to improve patient safety. The previous regulations were outdated and did not adequately address the risks associated with these devices. The new EU Medical Device Regulation (MDR) and ...Read more

ISO 13485 Quality Policy

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 your Quality Policy (requirement 5.3). So, you may wonder what this ISO 13485 Quality Policy statement is and why it ...Read more

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 Brkic TABLE OF CONTENTS What is technical documentation? What is the structure of the technical documentation? What are the MDR technical documentation requirements? Device description and specifications, including variants and accessories Information to be supplied ...Read more