First speaker announced – Medical Device Product Life Cycle Conference

Make compliance your success factor –  a conference for QA/RA professionals We are delighted to introduce the first speaker Cyrille Michaud at our upcoming conference on the 26-27th of Ocotober in Lund, Sweden. The title of Cyrille’s presentation is “Device Software and Change control – how can SW manufacturers manage changes under MDR?”  Short introduction […]

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 […]

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 […]

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 […]