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 […]
A New Year’s message from CEO Jan Hellqvist
Dear valued Customers and Partners, As 2021 draws to a close I want to take this opportunity to look back on a year at Key2Compliance focused on the construction of a foundation for continued future growth and internationalization. Our purpose at Key2Compliance is to improve patient safety. This purpose together with our vision to make […]
Merry Christmas and Happy New Year!
As we are about to leave another year behind us, we at Key2Compliance want to wish everyone a very merry Christmas and give our heartfelt thanks to everyone who has made 2021 a fantastic year. Thanks to all these amazing connections we have been able to share knowledge, joy, and inspiration with so many wonderful […]
Emma Pedersen banar väg för alternativa testmetoder som är regulatoriskt accepterade
Den 19 november talar PhD Emma Pedersen på ett webbinar om validering av djurfria metoder som är arrangerat av Sveriges 3R-center. Emma är Director för Biological Safety hos Key2Compliance där hon leder ett team som jobbar med att säkerställa att medicintekniska produkter är biologiskt säkra. Emma har tidigare arbetat mycket med ersätta djurförsök med så […]
The Company Ensuring Oversight in Medical Device Trials
As the “Best Clinical Development and Regulatory Compliance Firm” in 2021 for Sweden, Key2Compliance it making itself a partner to medical device creation companies. By making sure the clinical trials conducted on such products are thorough, comprehensive, and detailed, granting businesses the oversight they need to reassure buyers of the quality and compliance of their […]
Thank you for attending the Biological and Clinical Evaluations Conference for Medical Devices
Thank you to all our delegates, speakers, moderators, and exhibitors for making the Biological and Clinical Evaluations Conference for Medical Devices such a positive, interesting, inspiring, exciting, and fun two days! It was wonderful to meet you all in Malmö! We hope to see you next year!