Career at QAdvis

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.

Read more here

Welcome Noomi

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.

Read about technical documentation here.

 

2-day course EN ISO 13485:2016

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