Entries by Johnnie Dahlberg

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 […]

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

Update of the guidance for medical device software applications (apps)

MHRA (Medicines and Healthcare Products Regulatory Agency) has published an update of the guidance for medical device software applications (apps). The guidance provides information on when software applications are considered to be medical devices and how these shall be regulated. The guidance consists of an overall document and three appendices. • Medical Device stand-alone software, […]