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.
Swedish Medtech Summit 2023
QAdvis är så klart representerade på höstens Swedish Medtech Summit den 21 november i Stockholm. Kom och prata med våra konsulter Ladan Amiri och Krishnadev Moothandassery Ramdevan. Konferensen kommer ge en belysning av hur vården– och omsorgen håller på att utvecklas och hur stor betydelse de nya teknikerna kommer ha i framtiden. Som konsultföretag inom […]
Is it time to scrap the DHF, DMR and DHR?
To successfully navigate an inspection by FDA, it’s essential to maintain three separate buckets for your device files: the Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR). However, with the upcoming update to the US Quality System Regulation, these terms may no longer be used. Since 2018, the […]
FDA issues a new version of ISO 10993-1 guidance, which impact devices with intact skin contact
In September 2023, FDA released a new version of their guidance “Use of International Standard ISO 10993-1”. In this version FDA guidance document , it is stated that: FDA agrees with the ISO 10993-1:2018 revision regarding focus on minimizing the “number and exposure of test animals by giving preference to in vitro models and to […]
Medicinteknikdagarna 2023
Upplever du att de medicintekniska regelverken är lite krångliga och ibland svåra att navigera i, kom och prata med oss. Vi finns i monter 113. Vi är glada att få vara med som utställare på årets upplaga av Medicinteknikdagarna (MTD) som anordnas av Medicintekniska föreningen (MTF). Utställningen kommer vara på BioClinicum-Nya Karolinska Solna och ni […]
Do you remember the FDA eSubmitter?
Over the years, the FDA has had several 510(k) submission programs to make the process more streamlined and effective. This was achieved by going from paper systems to e-copies, e–submitter and Electronic Submission Gateways (ESG). In 2021, eSubmitter was discontinued after the eSTAR Pilot Program was launched in 2020. So far, eSTAR has been voluntary […]