Strengthening the QA&RA team!

We warmly welcome our new colleague Lisa Lundberg Dellenvall in joining the QA&RA consultant team. Lisa has a Master’s degree in Chemistry and brings a wealth of experience from the international medical device industry. In particular, she is very well versed to bring clarity and stability in potentially complex design control processes. Further, her expertise and hands-on style are highly appreciated in managing cross functional quality and regulatory projects. Lisa is based at QAdvis’ Lund office.

Read more about our services in Medical Devices – Development.

Midsummer weekend and Sweden’s summer holiday

Hello,
this year’s Midsummer weekend, and the start for Sweden’s summer holiday season is just a few days away.

For many of us, both working and everyday life became completely different, starting from March 2020. QAdvis has since then conducted its operations almost entirely on a remote basis. Different solutions made it possible to follow through within our projects, courses and seminars and to continue to offer our services without interruption.

We don’t know what the new “normal” is going to look like. What we do know, however, is that we will continue to carry out our services, we are still offering open and client specific courses as well as free seminars.

If you have missed out on any of our free seminars, you also have the opportunity to see them afterwards here: Previous presentations

Do you have questions or want to know more about us and our services, please contact us at info@qadvis.com, or follow us on LinkedIn and if you have questions or concerns regarding our course and seminars, you can always reach us at academy@qadvis.com.

My colleagues and I hope that you have a really nice summer, and as the community is slowly reopening we look forward to welcome you personally at our premises in Lund or Kista.

 

Kindly Regards
Hermine Redl, Office Manager at QAdvis

 

 

Date of Application for the Medical Device Regulation

Today, May 26, 2021, is the Date of Application for the Medical Device Regulation (MDR 2017/745), one year later than initially planned.

Over the past years, focus has been on the new regulatory requirements for all economic operators, and the pieces are finally starting to come together.

For manufacturers, developing the technical documentation and implementing Article 10 requirements in the quality management system, as well as ensuring sufficient clinical evidence for all medical devices, is mandatory to be able to continue to keep them on the market as CE-marked according to MDR.

Irrespective of existing certificates and softer transition for certain product classes, a system for post market surveillance and vigilance must be in place by today for all manufacturers.

Next to come – The corresponding date of application of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) on May 26, 2022.

MDR process

Technical documentation for CE marking

 

Very welcome Frederik Roos!

We are very happy that Frederik has joined our team. Fredrik will hands-on support our clients to safely and effectively navigate through the product development aspects in a regulated environment.
He has 12 years of experience from the medical device industry with many leadership roles within international product development. Frederik holds a M.Sc. in Chemistry and a B.Sc. in Chemical Engineering.