The new version of Annex 1 is published, finally!
Key2Compliance has prepared for the publication for a long time and we have webinars, training courses and consultation services ready to support you. First out is a webinar together with the Danish Medicines Agency on October 11th. After that, we run a number of courses on Annex 1 and related subjects like Contamination Control Strategy […]
Speaker announcement: Sofia Segersson from Diabetesia
Medical Device Product Life Cycle – a conference for QA & RA professionals! We are happy to welcome the next speaker to our Medical Device Product Life Cycle – QA/RA conference on the 26-27th of October in Lund: Sofia Segersson, Owner, Consultant, Entrepeneur at Diabetesia.se Sofia will speak about a very interesting topic “Medical Devices as Part of […]
Speaker announcement: Judith de Wilde from Axon Lawyers
Make compliance your success factor – a conference for QA/RA professionals We are delighted to welcome the next speaker to our Medical Device Product Life Cycle – QA/RA conference on the 26-27th of October in Lund: Judith de Wilde, Attorney at Law at Axon Lawyers Judith will deliver two presentations at the conference: Interaction between manufacturers […]
A warm welcome to our two new team members!
We are glad to share with you that our Key2Compliance team has recently been joined by two new team members – Erik and Susanna. We are excited to introduce you to these two talented additions to our team! ERIK BOM, Medical Device QA/RA Consultant What will be your role at Key2Compliance? I will work as […]
Inside Medicon Valley
Don’t miss the article about Key2Compliance in the new magazine “Inside Medicon Valley”. The article focuses on “The survival of devices following EU-MDR and FDAs more stringent scrutiny on clinical data”. Inside Medicon Valley is a new magazine, highlighting what’s happening in the Swedish-Danish life science region. Medicon Valley is the strongest life science cluster […]
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 […]
IVDR brings stricter regulations for In Vitro Diagnostic medical devices
In 2016, the European Commission decided to gradually introduce a new mandatory regulatory framework for IVDs: IVDR (In Vitro Diagnostic Medical Device Regulation). The new regulations will replace the old In Vitro Diagnostic Medical Devices Directive IVDD on May 26, 2022. We know that it can be overwhelming to get an understanding of the new […]
Vitalis 2022 – Join our presentation on the 17th of May
Are you a manufacturer of a medical device software and curious to know more about clinical evaluation? Then you should visit Scandinavia’s largest eHealth event, Vitalis 2022, next week and listen to Johanna Fugelstad presentation. She will talk about clinical evaluations and highlight some basic and important concepts of the process. Date: 17th of May Time: […]
Welcome to the team!
Exciting times at Key2Compliance as we continue to grow and welcome another three new team members! Please join us in welcoming Anna Sahlholm, Zahra Mavajian and Kristina Edner to our great team. ANNA SAHLHOLM, Senior Consultant Clinical Development What will be your role at Key2Compliance? I will work in the team of clinical development […]
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 […]