Meet Gustav Sundström, one of our electrical safety experts!
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, […]
Meet Malin Truvé, one of our Usability Evaluation experts!
Usability evaluations for better safety and design of medical devices Usability evaluations are connected to the risk management and is an important part of the technical documentation. Performing formative and summative evaluations will make sure that the user of the medical device can use it safely. Usability evaluations are not only important for the sake […]
Meet Oscar He, our Senior Consultant and Coordinating Manager for internal audits!
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 […]
A very warm welcome to our newest team members!
Let us introduce our newest colleagues: Linda Hansson, Tatiana Mattsson and Susanne Grimsby! 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. LINDA HANSSON, Consultant Clinical Development What will be your role at Key2Compliance? I will be part […]
Ny i rollen som RA – unik kurs i samarbete med Swedish Medtech
Vill du känna dig säkrare i din roll inom Regulatory Affairs? Tillsammans med Swedish Medtech erbjuder vi nu en unik möjlighet med kompetensutveckling för dig som är ny i din roll! Under kursen får du kunskaper om Regulatory Affairs i de olika stegen från produktidé till färdig produkt och eftermarknadskrav. Föreläsare är Åse Ek och Anna […]
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 […]
Time is running out – Join our conference!
We are beginning our countdown until our Medical Device Product Life Cycle Conference on October 26-27th! We are thrilled to see how many of you have signed up to join us. There are still some spaces left. If you haven’t yet registered, but are thinking about doing so, we encourage you to REGISTER NOW to […]
Meet Christoffer Ekström at the Medical Device Product Life Cycle conference
We are thrilled to announce that Christoffer Ekström, CEO at AI Medical Technology will one of the speakers at our conference “Medical Device Product Life Cycle” in October. 𝐅𝐫𝐨𝐦 𝐮𝐬𝐞𝐫 𝐧𝐞𝐞𝐝 𝐭𝐨 𝐩𝐫𝐨𝐝𝐮𝐜𝐭 𝐬𝐩𝐞𝐜𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 – 𝐚 𝐫𝐞𝐚𝐥 𝐰𝐨𝐫𝐥𝐝 𝐞𝐱𝐚𝐦𝐩𝐥𝐞 Christoffer will share his story on how AI Medical Technology matched a critical user need with innovative technology and […]
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 Key2Compliance […]