Is your Medical Device Software ready for MDR?

The clock is ticking for MDR. The Medical Device Regulation (MDR) is fully applicable since May 26th 2021, and no later than May 26th 2024, all medical device software must be compliant with MDR. To make your medical device software MDR compliant, we recommend you to: Update or create your QMS Update or create your […]

Welcome to Our Newest Team Members!

We are happy to announce that our team at Key2Compliance continues to grow steadily with another four new team members joining us. Please welcome Susanne El Makdisi, Oskar Öhman, Carmen Vogt and Christina Ehrenkrona on board!   SUSANNE EL MAKDISI, Medical Device QA Consultant What will be your role at Key2Compliance? My role will be […]

Do you need to update your Quality Management System because of MDR?

Is your Quality Management System compliant with the new MDR requirements? If you need to update your QMS because of the changes in the MDR, we have the perfect package deal that will keep you ahead of the game and compliant with the requirements. A 3-hour online training session in ”MDR audit readiness”, giving you […]

Free webinar: Is your medical device software MDR ready?

There are lots of great ideas and products related to medical device software today. Many of them already are compliant to the Medical Devices Directive (MDD), others are in an earlier development state. Since May 26th, 2021, the Medical Devices Regulation (MDR) is in force and latest May 26th, 2024, all medical device software has […]

Making complex things easier in Medical Device

Keeping track of Regulatory affairs, Quality Assurance, Clinical Development, ICH guidelines and Biological Evaluations is not a walk in the park. The task requires years of hands-on experience and well-established collaboration networks, as well as the ability and tools to monitor continuous changes and updates of current regulations. Pharmaceutical companies, In-Vitro Diagnostic Companies and Medical […]