Update on situation with Covid-19, January 2021

The ongoing situation with Covid-19, the further extended time range on recommendations to work from home, as well as the maximum allowed number of participants in meetings/events, maintains our limitations regarding visitors in our office premises.

In order to eliminate any risk of QAdvis hosted events, keeping both employees, clients and colleagues protected from possible infections, QAdvis have decided to extend the time range on offering our courses and breakfast seminars remotely until August 2021.

The current situation has led to several solutions where remote work, courses and communication is possible, and QAdvis can continue to offer our services without interruption.

Our offices in Lund and Kista are open but with very limited on-site personnel and we hope the situation will normalize as soon as possible. We can always be reached by phone (+46 8 621 01 05) or e-mail (info@qadvis.com).

Stay safe and healthy

IEC TR 60601-4-5 is now published
– an important step in the Cybersecurity work

Today we have the pleasure to announce that the cybersecurity technical report IEC TR 60601-4-5 has been published. The not so short title of this report is:
Medical electrical equipment – Part 4-5 Guidance and interpretation – Safety related technical security specifications for medical devices

This technical report contains concrete cybersecurity requirements to be implemented both in a device with embedded software and Software as a Medical Device.

Two QAdvis consultants were active participants in the project group, which has been working for two years on this report.

Swedish link: https://elstandard.se/standard/2586001

International link: https://webstore.iec.ch/publication/64703


Our Due Diligence consultants are ready to support you

A well performed due diligence process is challenging but crucial in any merger and acquisition (M&A) decision or investment planning. It is fundamental for the acquiring party to get a sound assessment of the quality, regulatory and clinical evidence situation to understand any potential risks and vulnerabilities. The medical device regulatory landscape is complex and changing.

Strengthening the due diligence team with a QAdvis Medical Device quality/regulatory expert or clinical expert will significantly increase the chances of a successful project. Our team is working according to a defined and well proven due diligence model that is adapted to each project. Each project is unique and deserves its individual setup.

A due diligence is different from compliance audits and the team members use all experience to prioritize and select review–segments correctly along the investigation process within the time budget.

You can trust our confidential, professional, and respectful engagement.

Read more about Due Diligence here

Strengthening QAdvis management roles with COO, CSO and CMO

To meet the increased demand of our services QAdvis has expanded its business significantly the last years. We have in December in addition formalized three management roles.

Chief Operation Officer: Emma Axelsson. This includes the role as Deputy CEO
Chief Sales Officer: Per Sundström
Chief Medical Officer: Cecilia Emanuelsson

In our new Edinburgh based office QAdvis UK Ltd. Per Sundström is also appointed as Deputy Managing Director

It is a pleasure to welcome our great colleagues into their new roles and we wish them the best of luck. We are convinced this will strengthen our internal structure for the benefit of our clients.