QAdvis participate in Regulatory Summit 31, March

Meet our new CEO Emma Axelsson and listen to three of our consultants Cecilia Emanuelsson, Nils Lidström and Per Sundström at the upcoming Regulatory Summit hosted by Swedish Medtech on March 31.

For the 5th year in a row, Swedish Medtech is holding a regulatory conference and interest in the subject is growing every year.

QAdvis both exhibits and has several speakers at this years Swedish Medtech Regulatory Summit. Come and meet us in our stand and take the opportunity to listen to our business offer, our visions for the future and ask your questions directly. In addition, you also have the opportunity to listen to some of our consultants presenting during the day.

There will also be presentations by the Swedish competent authority for medical devices (Läkemedelsverket), and MedTech Europe will give a picture of the complex reality and challenges ahead.

Take the opportunity and visit us in our exhibitor stand at Regulatory Summit, this year at Hilton, Slussen in Stockholm, 31 March.

Read more here – Regulatory Summit Swedish Medtech

New CEO at QAdvis AB!

The Board of Directors at QAdvis is delighted to announce that Emma Axelsson has accepted the role of CEO, effective from February 1st 2022.

“It is truly a pleasure to hand over this executive role to Emma. She has over the years gained a huge competence in the Medical Device area and is truly a natural leader.

Emma has previously worked from a COO role and we are very confident that she will continue to spearhead our team efforts as a world class service provider of quality and regulatory services.”

Publication of Regulation (EU) 2022/112

–A Risk based roll-out plan for certain In Vitro Diagnostic medical devices and In-house devices

On 28 January 2022 the Regulation (EU) 2022/112 (CELEX number 32022R0112), amending new and updated transitional provisions to the IVD Regulation (EU) 2017/746, was published in the EU’s Official Journal after being signed on 25 January 2022 by the Presidents of the European Parliament and Council.

That means that this amending Regulation is now binding in its entirety and directly applicable in all Member States.

However, the amending Regulation does not change any requirements of the original IVD Regulation. It only changes requirement related dates of application identified in IVD Regulation (EU) 2017/746 articles 110, 112 and 113 for certain IVD medical devices including in-house devices.

The purpose of Regulation (EU) 2022/112 is to prevent disruption of supply of essential healthcare products in the context of the COVID-19 pandemic. All manufacturers need to control how the amending regulation affects transition times for each device.

 

Welcome to QAdvis!

We are very pleased to welcome a new consultant, Nils Lidström to our QAdvis team!

Nils has a master’s degree in system engineering and over 25 years of working with software development, the last 6 years with medical device software development using agile methodologies. Key areas of expertise are regulatory requirements and how to adapt procedures and use tool-based support to achieve compliance while minimizing documentation workload. Nils is based out of QAdvis’ Stockholm office.

Read more about our services Software Quality Assurance.