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.
Christmas Rhyme 4th Advent
Internal Audit (ISO 13485:2016 clause 8.2.4) The fourth of advent is finally here, and Santa is tired after an intensive year. They now need to finally assess, So they audit their entire QMS. Santa needs to put together his most talented team, and start with a well-planned audit scheme. The Elves shall audit with a […]
Christmas Rhyme 3rd Advent
Risk Management in Product realization (ISO 13485:2016 clause 7.1) Managing risk plays an important role to improve the Company and be in total control. The Elves evaluate the hazards and risks in several ways and they have to work for seven days. Exhausted and tired they really need a break, to celebrate the third Advent […]
Christmas Rhyme 2nd Advent
Management responsibility (ISO 13485:2016 clause 5) The second of advent is coming up have the Elves managed the IT-backup? Santa is stressed and the deadlines fills his mind, the final QMS-approval need to be signed. His Company is a Legal Manufacture, and they need sufficient infrastructure. Quality objectives, regulations and software tool, so the CEO […]
Christmas Rhyme 1st Advent
Design and development (ISO 13485:2016 clause 7.3) Christmas is coming and today is advent, but Santa and his Elves are not ready yet. Is the processes deemed sufficient and good, or can anything be totally misunderstood? Design Control is almost the trickiest part, Santa and his Elves need to be talent and smart. To ensure they […]
Great news! QAdvis has received the “Gasell Company 2021” award from Dagens Industri.
This is great fun and we are obviously very honored and proud! We are so grateful to our clients, our team and of course Dagens Industri, the biggest daily business paper in the Nordic countries. The Gasell business requirements to be met extend over a three-year period and need to be achieved by organic growth. […]