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 […]
Improve your risk management procedures
ISO 14971:2019, the internationally harmonized standard, stating how to reduce risks, increase patient safety and ensure that you as a manufacturer can bring your medical devices to the market safely and efficiently. Our new course will give you a thorough understanding of ISO 14971:2019 and how adopting the internationally harmonized standard early in the process […]
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 […]
Key2Compliance celebrates announcement from Atrogi
Key2Compliance celebrates that Atrogi has received approval from the German authority BfArM to initiate a phase 1 study with their small molecule drug candidate ATR-258 in healthy volunteers and Type 2 Diabetics. Atrogi is one of Key2Complience clients and an early-stage Swedish pharma company developing a novel solution for the treatment of Type 2 Diabetes. […]
Welcome to our five new team members!
Our team keeps growing and we are delighted to welcome five new employees to Key2Compliance! We are happy to present to you Gustav Sundström, Joanna Jackson, Marika Lundin, Gunilla Zetterholm and Malin Truvé. They are all a fantastic addition to our team of senior specialists. GUSTAV SUNDSTRÖM, Consultant Regulatory Affairs What will be your […]
Meet our four new team members!
Our team keeps growing! We are very happy to welcome our newest colleagues Kristina Fant, Evelina Philipson, Anastasija Eschricht and Beatrice Burtsov 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. KRISTINA FANT, Senior Consultant […]
Welcome to Our Newest Team Members!
2022 brings exciting new opportunities to Key2Compliance, and with those we are happy to welcome no less than four new colleagues to our rapidly growing team. We are excited to introduce them to you, so please welcome Sandra Sernbo, Emily Malmberg, Winta Woldai and Nhung Södergren! SANDRA SERNBO, Consultant Clinical Development What will be your role […]