News from QAdvis

2019 was an exciting year for us at QAdvis!

Hermine Redl, Office Manager, and Bing Wu, E.A.R. Manager and Quality and Regulatory Consultant at our Kista office and Caroline Ehrenborg, Quality and Regulatory Consultant at our Lund office are all very welcome new members on our team.

We have taken part in a number of conferences this year, including RMD USA, RMD Europe, RAPS USA and Swedish Medtech Summit 2019, in coordination group meetings with Swedish Medical Products Agency (LMV) and Swedish Institute for Standards (SIS) and we have participated in standardization work groups within the fields of cybersecurity, quality management systems and risk management (including IEC/TR 606001-4-5, IEC 80001-5-1, TK355). We have given presentations and we have been trade fair exhibitors, actively participating in all of these events to keep up to date on the developments and latest news within regulations, standards and guidelines.

Our breakfast seminars and courses, both our own and those that we have arranged in collaboration with Swedish Medtech and Intertek, have been popular events.

QAdvis wishes all our customers and partners a Merry Christmas and a Happy New Year!

We refrain from physical christmas gifts and choose to support the Swedish Childhood Cancer Foundation (Barncancerfonden) in their effort to prevent and combat cancer diseases in children.

Read our Diploma (Swedish).

Link to the Swedish Childhood Cancer Foundation (Swedish).

October has been a busy month for us here at QAdvis

This week, Robert Ginsberg, QAdvis’s Chairman of the Board, was speaking at RMD in Brussels, our consultants have been participating as speakers at several events, including SARQA´s autumn meeting and MEDEA autumn meeting as well as participating in a meeting with Läkemedelsverket (Swedish Medical Products Agency).

We have also hosted our new 2-day course in Risk Management in cooperation with Swedish Medtech for the first time, and it was a success! We are looking forward to another eventful month, November being just around the corner. Read more about upcoming QAdvis Academy courses on our website!

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.