To our offices in Lund and Stockholm we are now looking for new colleges that will work together with us and our clients as Quality & Regulatory consultant within the Medical Device and In Vitro Diagnostic medical device industry.
We are very pleased to announce the joining of our new colleague Noomi Altgärde and extend a warm welcome to the QA&RA consultant team at QAdvis!
Noomi has a PhD in Bioscience and a long background from working with medical devices in the development phase, with a focus on quality assurance and regulatory affairs. Her curiosity and broad background within both research and product development gives an excellent platform to understanding the complexities medical device manufacturers will face, simplifying regulatory requirements and finding hands-on solutions for both manufacturers and other stakeholders.
The harmonised EN ISO 13485:2016 standard can be used to show compliance with the regulations and constitutional requirements needed for companies supplying medical devices and associated services in the EU
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.