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.
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 […]
Do you as a medical device manufacturer consider the intended environment of use when you design alarm sounds?
Based on experience in emergency/intensive care and equally within the medical device industry, we have learned that some companies have difficulties to clearly define the circumstances where the devices are intended to be used. It is common that same type of device can be used in a multitude of different environments. So why does this […]