Navigating Medical Device Regulations – Insights from Our Danish Consultants

Cecilie Bengtsen, Mia Trustrup Larsen, and Nadia Ragnvald Caspersen Key2Compliance has in the past two years expanded its Nordic presence with a dedicated team of regulatory compliance consultants in Denmark. The expansion is timely, given the increasingly stringent compliance requirements for medical devices introduced by the Medical Device Regulation (MDR) and the In Vitro Diagnostic […]

Meet Oscar He, our Senior Consultant and Coordinating Manager for internal audits!

Oscar He

Internal audits – an opportunity to improve medical devices Internal audits are an important activity for medical device manufacturers. They are not only a requirement for ISO 13485 compliance, but also an opportunity to get valuable feedback that can help to improve both the medical device and the development process. Oscar He is coordinating the […]

Thank you for attending our conference!

Key2Compliance this week hosted for the first time the Medical Device Product Life Cycle Conference, and we could not be any happier! Thanks to all the committed participants, speakers, and exhibitors for two fantastic days and for making this a success. Also thank you to our excellent moderator, Magnus Fyrfalk, who took on the task […]

Welcome to Our Newest Team Members!

Our team keeps growing! We are very happy to welcome our newest colleagues Johan Grahn, Jonas Jägerback and Lars Mentzer on board. They are joining forces with us to help continue doing what we love to do: make complex things easier – all the way from idea to market. JOHAN GRAHN, Senior Consultant Regulatory Affairs What […]

Welcome to the team!

Welcome our newest rockstars to Key2Compliance, Heléne Lindegren, Malin Borg, Dalia Rhman och David Dahi. Four individuals who are joining us and no doubt will have a huge impact on their clients and teams! Welcome to the team!   HELÉNE LINDEGREN, Business & Contract Manager What will be your role at Key2Compliance? My role at […]

Welcome our next speaker – Åse Ek!

Medical Device Product Life Cycle – a conference for QA & RA professionals! Let’s welcome our next speaker in line , Ase Ek, Senior Consultant and Trainer at Key2Compliance to our Medical Device Product Life Cycle conference!! 𝗕𝗲𝗶𝗻𝗴 𝘁𝗵𝗲 ‘𝗣𝗲𝗿𝘀𝗼𝗻 𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗹𝗲 𝗳𝗼𝗿 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲’ – 𝗶𝘀 𝘁𝗵𝗶𝘀 𝗶𝗻 𝗳𝗮𝗰𝘁 𝗮 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗰𝗼𝗻𝘁𝗿𝗼𝗹, 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗮𝗳𝗳𝗮𝗶𝗿𝘀, 𝗼𝗿 […]

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 […]

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