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!
Making complex things easier in Medical Device
Keeping track of Regulatory affairs, Quality Assurance, Clinical Development, ICH guidelines and Biological Evaluations is not a walk in the park. The task requires years of hands-on experience and well-established collaboration networks, as well as the ability and tools to monitor continuous changes and updates of current regulations. Pharmaceutical companies, In-Vitro Diagnostic Companies and Medical […]
New office in Gothenburg
We are happy to announce the opening of a brand new office in Gothenburg. Last year we moved in to the new head office in Stockholm and simultanousely we opened an office in Lund. Our business is growing and we need an office in western Sweden and the location next to Chalmers University of Technology […]
How and when to update your Clinical Evaluation Report (CER)
In general a CER needs to be updated anywhere from at least annually, up to every 5 years, depending on the risk class and how well-established the device is – definately it should be updated after certain trigger events. Learn more about this by watching this video and by taking part in our course “Clinical […]
LMV informerar om kliniska prövningar relaterat till MDR
Hur vet jag om en studie är en klinisk prövning av medicinteknisk produkt? Läkemedelsverket har tagit fram en film för att förtydliga vilka kliniska studier som omfattas av bestämmelserna i det nya regelverket om medicintekniska produkter.
Key2Compliance® sitter med i flertalet Tekniska Kommittéer
Tekniska Kommittéer har i uppdrag att utarbeta, upphäva och revidera svensk standard och medverka i internationellt standardiseringsarbete. Läs mer om arbetet med framtidens standarder. Läs mer om SIS standardutveckling →
Free BSI Webinar – UKCA for Medical devices and IVDs, are you ready?
Free live webinar Join BSI’s Dr Jayanth Katta, Head of UK Approved Body, Regulatory Services, to hear the latest updates on Brexit and the new UK Conformity Assessed mark (UKCA) for medical devices. More information: https://www.bsigroup.com/en-GB/medical-devices/brexit-medical-devices/ Register: Tuesday, 12 January, 2021 9:00 – 10:00 GMT Tuesday, 12 January, 2021 16:00 – 17:00 GMT