We are delighted and proud to announce that QAdvis Group has achieved ISO 13485:2016 certification. This is a major milestone and demonstrates our commitment to provide high quality consulting services and we are now better positioned to consistently meet and exceed our clients’ expectations.
With a solid background from Medical Affairs in MedTech industry and academic Life Science research, Kecke is skilled in clinical/scientific reading, writing, and interpretation. She is well-experienced in clinical evaluation, post-market clinical follow-up, clinical evidence gap identification, systematic literature search, and claims substantiation for regulatory purposes. Kecke is used to provide Medical Affairs input to Technical Documentation, risk assessment, product design development projects, clinical study strategies and marketing material.
Appreciated for being a direct and service-minded self-starter with high personal standards, professional integrity and strong focus on the end-product, Kecke is a knowledgeable partner, always prepared to work around issues to find solutions.
Kecke is part of the Lund office team but most of the time you will find her in her home-office in Mölndal.
QAdvis is now officially part of Aurevia. This change of name follows our company’s integration into Aurevia. The Aurevia brand was born in January, when Labquality, Artimed, Clinical Consulting, Kasve, and Prisma CRO merged under the same name. With QAdvis now proudly joining the team, we are further strengthening our expertise and services and together offering greater value to our joint customers. Scandinavian CRO is also joining Aurevia.
