MDR support for meeting regulatory requirements
...a broad range of resources, expertise, and services, who can provide you with continuous support over the implementation and transition period to MDR.Customized MDR services to meet your specific needs:...
MDR
...to meet their requirements. The course is also held in collaboration with Swedish Medtech. The medical device industry is subject to the Medical Device Regulation (MDR) and all medical devices placed on the market are...
MDR and IVDR support for healthcare
On May 26, 2021, the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices entered into force in the EU, the MDR, and on May 26, 2022, the Regulation for in vitro diagnostic...
MDR
...medical device regulation ( MDR), the process of CE marking and insight into quality management systems for medical devices (according to ISO 13485). After the course you will have insight and knowledge of MDR to be able to help...
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
...with the Medical Device Regulation ( MDR), the CE marking process and insight into quality management systems for medical devices (according to ISO 13485). After the course, you will have insight and knowledge of the MDR to be able to...
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
...either on its own (SaMD) or in combination with specified hardware, for a purpose specified in the definition of a "medical device" under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation....
Software for medical devices
activities. SKILLS To benefit from the course you need to have a basic understanding of the MDR, the medical device regulation. We recommend that you have attended some of our basic MDR courses....
Software for medical devices
activities. SKILLS To benefit from the course you need to have a basic understanding of the MDR, the medical device regulation. We recommend that you have attended some of our basic MDR courses....
Software for medical devices
activities. SKILLS To benefit from the course you need to have a basic understanding of the MDR, the medical device regulation. We recommend that you have attended some of our basic MDR courses....
The "Medical Device Software" course gives you the basics you need to know
is to identify and minimize cybersecurity risks. In the course "Software for medical devices" we give you an overall view of the requirements introduced for software with regard to MDR. Have...
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,...
Senior QA/RA consultant in MedTech/IVD
...you will excel with us: You have worked with MDD/MDR, IVDD/IVDR, ISO 13485, ISO 15189, ISO 14971 or 21 CFR Part 820, FDA applications and MDSAP. You have...
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...
Webinar: Strategies for software documentation and Notified Body application - for MedTech & IVD.
...120 i MDR. Speaker Magnus Olla, Business Development Manager, Medical Devices - Nordics, BSI. Magnus joined BSI in 2021, bringing his regulatory & commercial expertise and passion for sales &...
Compliance Excellence Day 2023
...of the Research-Based Pharmaceutical Industry Self-manufacturing Hall 3 Self-manufacturing under MDR - how does it affect healthcare? What are the challenges and how can they be addressed? Pascal Skoglund Head of Unit PVC Skåne /...