Join us in boosting MedTech knowledge together! On October 8 and 9th, 2024, Key2Compliance is delighted to once again host the highly appreciated Conference, “Medical Device Product Life Cycle”, this time in Stockholm! We’re honored to have four Notified Bodies joining us as featured speakers at our event: BSI, RISE, Intertek, and TÜV SÜD. Featuring […]
The European Commission published Regulation (EU) 2023/607 in early 2023 which specifies conditions for extending the deadlines for medical device manufacturers transitioning from MDD to MDR and removing the “sell off” period. The regulation was published to minimize impact on healthcare services caused by device shortage, to prevent unnecessary disposal of safe devices and to […]
It has been predicted that 50% of all medical device products on the European market will vanish after the MDR curtain has fallen. This produces huge opportunities for companies that are proactive and understand that MDR is not a problem but rather an opportunity. The biggest impact on life for medical device companies following MDR […]
What you need know about electrical safety for medical devices according to the IEC 60601-series Electrical safety in medical devices is very important to ensure the safety of both patients and caregivers. The regulatory world of medical electrical devices can seem complex at times, especially with the transition to MDR and its new requirements. But, […]
Key2Compliance Coordinating manager for PRRC explains what you need to know about the new required role of Person Responsible for Regulatory Compliance The new medical device regulations MDR and IVDR have introduced a new role: Person Responsible for Regulatory Compliance (PRRC). According to Article 15 of MDR and IVDR, manufacturers of medical devices are now […]
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 […]
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 […]
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 […]
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 […]
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 […]
