News from QAdvis

Finally released – Guideline for medical device SW i EU

We think that many of you have waited for the guideline for medical device SW in EU!

“Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR”

Direct download link

Link to European Commision

A short introduction – 191014
Intro to the MDR & IVDR SW Guidance (download link)

The 4th EAAR Annual Conference on New Medical Device Regulations

Robert Ginsberg, Chairman of the board at QAdvis and board member of European Association of Authorized Representatives (EAAR), is one of the speakers at RMD 2019.

The event takes place in Brussels on 28–29 October, 2019, with an impressive list of competent speakers, including industry experts, and speakers representing EU Com, Notified Bodies, Legal and MedTech Europe. Robert’s speech on the 29th is about Medical Device Software in the European Union. Read more about the conference, the agenda and the speakers at RMD Europe 2019 here.

Welcome to learn more about what is going on in this field, and to meet us at RMD 2019! Finally, don’t miss out on the unique opportunity to reserve your one-to-one meeting with the conference speakers.

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

We welcome Caroline Ehrenborg MSc who has just started as a QA&RA consultant. She will be a great addition to our team and will support clients specifically with her competence within device/drug combination products. She is well versed within R&D, MDD and MDR Technical documentation, implantable devices and biocompatibility.

It is also our pleasure to inform of the promotion of Emma Axelsson and Ekaterina Riabova to Senior QA&RA consultants. Both command the skills and have long proven track records of complete and autonomous management of client’s quality and regulatory responsibilities.

International Medical Devices Exihibition (CMEF) 2019 on 11–13 July.

QAdvis EAR Manager, Bing Wu, will visit the 25th China (Shanghai) International Medical Devices Exihibition (CMEF) 2019 on 11–13 July. She will meet with many of the exhibitors, both Chinese and international visitors, as well as our customers.

Read more about the exhibition here:
http://www.chinaylqxexpo.com/English/index.asp

Lumito has chosen QAdvis to support them in the CE-marking

QAdvis has signed agreement with Lumito, developers of imaging techniques for both tissue in living organisms (in vivo) and tissue samples in laboratory environments (in vitro). Lumito intend to introduce their medical imaging solutions on the European market, and QAdvis will assist them in the regulatory work involved in implementing a quality management system and composing a technical file, which are both required for achieving CE markings.

https://news.cision.com/se/lumito/r/lumito-anlitar-qadvis-och-startar-arbetet-mot-ce-markning,c2782010