News from QAdvis

We are pleased to share some great news about the further strengthening of our Quality and Regulatory team.

We welcome Krishnadev Moothandassery Ramdevan who has just started as QA&RA consultant, based in our office in Stockholm. He will be a great addition to our team. Krishnadev has his master’s degrees in Medical Engineering from KTH, Stockholm.  He has a background in software development and testing for pharmaceutical and life science companies, with an […]

Various interesting events during springtime

Our collaboration with Swedish Medtech has been successful since 2018 and we are proud to participate in the Swedish Medtech Regulatory Summit 2021. Senior Quality and Regulatory consultant Anna-Karin Areskog will make a presentation on the latest status regarding IVDR implementation. QAdvis consultant will during the spring be part in several presentations in the MedTech4Health […]

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 […]

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 […]

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 […]