IVDR support for meeting regulatory requirements
Support for transitioning from IVDD to IVDR Compared to the IVDD, the IVDR has introduced new requirements for all types of IVD products, for quality management systems of manufacturers, for...
IVDR
...Directive (IVDD) with the new In Vitro Diagnostic Regulation (2017/746) ( IVDR) to which the in vitro diagnostic industry is subject. This course gives you an introduction to the new IVDR and...
MDR and IVDR support for healthcare
...instruments and systems (EU) 2017/746, IVDR. The new regulations for medical devices have been followed by new laws at national level, introducing many new and expanded requirements both on manufacturers...
MDR & IVDR
An introduction to MDR & IVDR especially for those who have the role of importers or distributors The medical device and in vitro diagnostics industry is subject to the Medical Device Regulation (MDR) and In Vitro Diagnostics ( IVDR )...
MDR & IVDR
An introduction to MDR & IVDR especially for those who have the role of importers or distributors The medical device and in vitro diagnostics industry is subject to the Medical Device Regulation (MDR) and In Vitro Diagnostics ( IVDR )...
MDR & IVDR
The course is aimed at importers and/or distributors involved in the regulation of medical devices under the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation ( IVDR). It...
MDR & IVDR
An introduction to MDR & IVDR especially for those who have the role of importers or distributors The medical device and in vitro diagnostics industry is subject to the Medical Device Regulation (MDR) and In Vitro Diagnostics ( IVDR )...
The central role of medical software in life sciences: from pioneering research to strictly regulated use
(IVDR). One of software's main contributions in Life Science is the emergence of precision and personalized medicine. Software has also accelerated the drug development process through advanced simulation tools and virtual testing environments....
Medical software & AI
...extensive update from IVDD (In Vitro Diagnostic Medical Devices Directive) to IVDR (In Vitro Diagnostic Medical Devices Regulation) with increased requirements for detailed information on areas such as intended use, product classification,...
Cybersecurity for medical devices
...what does this mean for you as a medical device manufacturer and what measures will be required? One of the cornerstones of Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) is...
Consultant in Quality and Regulatory Affairs (QA/RA) Health Care
have a driver's license. If you also have experience in one of the following, you will shine with us: You have worked with one or more of the following: MDD/MDR, IVDD/IVDR, ISO 13485,...
Interview with Miranda - Young professionals program
...such as medical devices, invitro diagnostics and IVDR regulations. I have worked in hospitals and labs and have seen many areas of improvement, so it would be great to work on improvements and contribute to...
Webinar: AI and Medical Devices
...and overtrust, along with strategies to mitigate them. During the webinar you will learn more about the regulatory process for AI-enabled medical devices and compliance with MDR/IVDR regulations - straight...
Consultant RA/QA in Medtech/IVDs
...Swedish and English at a high level. You have experience in one of the following: You have worked with MDD/MDR, IVDD/IVDR, ISO 13485, ISO 15189, ISO 14971 or 21 CFR Part 820,...
