We are very happy that Frederik has joined our team. Fredrik will hands-on support our clients to safely and effectively navigate through the product development aspects in a regulated environment.
He has 12 years of experience from the medical device industry with many leadership roles within international product development. Frederik holds a M.Sc. in Chemistry and a B.Sc. in Chemical Engineering.
We are very pleased to welcome our new colleague joining our QA&RA consultant team. Mikael has a master’s degree and over 20 years of experience in product development and production from innovative companies within Life Science and Space Technology. Over the last 12 years he has been focusing on Quality Assurance and Regulatory Affairs management applied to medical devices and IVD devices. His broad industrial background and natural focus to always find efficient but compliant hands-on solutions to small/medium size companies’ quality and regulatory challenges is highly appreciated.
Read more about our services in Medical Devices – Development.
We welcome Krishnadev Moothandassery Ramdevan who has just started as QA&RA consultant, based in our office in Stockholm. He will be a great addition to our team.
Krishnadev has his master’s degrees in Medical Engineering from KTH, Stockholm. He has a background in software development and testing for pharmaceutical and life science companies, with an experience of around 7 years. During the past few years, he has focused on quality and regulatory work for medical device companies, helping them build their own QMS and aiding their software development process to be complaint with MDR, or according to relevant standards such as IEC 62304, ISO 13485, and ISO 14971. He is looking forward to further dive into the world of QA/RA along with the rest of the team
Read more about our services in Medical Devices – Development.
Our collaboration with Swedish Medtech has been successful since 2018 and we are proud to participate in the Swedish Medtech Regulatory Summit 2021. Senior Quality and Regulatory consultant Anna-Karin Areskog will make a presentation on the latest status regarding IVDR implementation.
QAdvis consultant will during the spring be part in several presentations in the MedTech4Health program to improve knowledge regarding quality and regulatory for medical device and IVD manufacturers.
The program is conducted in cooperation with Swedish Medtech and has more than 100 participants from different startups and small innovative companies within Sweden. QAdvis is proud to be part of this series of presentations, Senior Quality och Regulatory consultant Emma Axelsson is one of many, to inspire to early starting to include quality and regulatory issues in the development process.
Upcoming cooperating events are our established courses “Technical documentation” and “Clinical Evaluation”, with course leaders from QAdvis.
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.
