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 experience of around 7 years. During the past few years, he has focused on quality and regulatory work for medical device companies, helping them build their own QMS and aiding their software development process to be complaint with MDR, or according to relevant standards such as IEC 62304, ISO 13485, and ISO 14971. He is looking forward to further dive into the world of QA/RA along with the rest of the team

Read more about our services in Medical Devices – Development.

 

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 program to improve knowledge regarding quality and regulatory for medical device and IVD manufacturers.

The program is conducted in cooperation with Swedish Medtech and has more than 100 participants from different startups and small innovative companies within Sweden. QAdvis is proud to be part of this series of presentations, Senior Quality och Regulatory consultant Emma Axelsson is one of many, to inspire to early starting to include quality and regulatory issues in the development process.

Upcoming cooperating events are our established courses “Technical documentation” and “Clinical Evaluation”, with course leaders from QAdvis.

 

Swedish Medtech Regulatory Summit

Upcoming QAvdvis courses and seminars

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