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 a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.