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.
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 […]
Whenever you see a successful business, someone once made a courageous decision.
The above is a quote from Peter Drucker (1909 – 2005) the founding father of modern management studies. And nothing could be more true, especially if you decide to start a business in the medical device consulting industry. That is exactly what Robert Ginsberg and Nils-Åke Lindberg did in 2013 when they founded QAdvis AB. […]
Why having a second supplier could make sense even if it costs more.
Having dual sourcing of important components causes additional work, takes more time and negotiation price could be less successful with half the volumes. If you add this to the fact that you also double your suppliers with additional supplier control, validations and possible Notified Body involvement, the natural question would be: Why on earth would […]