Welcome to Barbara Musi

Barbara brings 25 years of experience as senior specialist in global support for biocompatibility strategy and toxicological risk assessment of products in development and sustaining products for dialysis systems and intensive care units at Baxter (previously Gambro AB), Lund Sweden. Most recently she worked for Altran as senior consultant toxicology and biocompatibility supporting MDR compliance. […]

Welcome to Andrea Björkman

Andrea will strengthen our growing consultancy services with focus on area Clinical Development. Andrea comes from an assignment as project manager at the Department of Medical Biochemistry and Biophysics, Karolinska Institutet at SciLifeLab. She has a strong knowledge in research methodology from studies in cancer biology and the cell’s response to genotoxic stress to maintain […]

Welcome to Terese Wasell

Terese Wasell joins Key2Compliance Regulatory Affairs team as senior consultant and she brings over 15 years of experience in regulatory affairs, 5 years in post market surveillance and complaint handling and also quality and compliance experience. Most recently she came from Roche Diagnostics Scandinavia AB and she have had previous positions at Olerup SSP AB/CareDx […]

Finally it’s here: the new ISO 10993-23 irritation standard

Finally it’s here: the new ISO 10993-23 irritation standard, presenting a real effort regarding the 3R’s in the field of medical device testing. As a member of ISO/TC 194/WG8 I have been involved in reviewing the proceeding draft versions of the standard, and my former colleagues at RISE did a great job in the underlying […]

We welcome our new co-worker Maria Victoria Ruiz Pérez

She will strengthen our growing consultancy services with focus on area business Biological Evaluations and Toxicology. Maria comes from an assignment as assistant Professor at the Department of Microbiology, Tumour and Cell Biology, Karolinska Institutet and she has a robust knowledge of the relationships between cell proliferation and metabolism, including signalling pathways and transcriptional control. Maria […]

FDA recognises the ISO 14155:2020 as a consensus standard

On December 21st 2020 FDA added ISO 14155:202 on the list of Recognised Consensus Standards. Worth noting is that the FDA highlights its application for post-market clinical investigations: “the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).” Read […]

FREE Webinar – An overview of IEC 62304 Medical Device software

Join us for this free webinar January 25, 2021  •  14.00-14.20 CET Learn more about how you can comply with the IEC 62304 standard in your Medical Device software development and maintenance process. When to apply IEC 62304? Overall development process for a medical device that is or includes Software Main points of IEC 62304 How to […]