EU Commission working on a proposal to postpone the new Medical Device Regulation for one year

Today (25 March 2020), the Commission announced that they are working to submit this proposal in early April for the Parliament and the Council to adopt it quickly as the date of application is the end of May.

 

This decision will relieve pressure from national authorities, notified bodies, manufacturers and other actors and will allow them to fully focus on urgent priorities related to the coronavirus crisis.

 

See video here

 

 

Covid-19 situation statement

 

In the current situation with Covid-19, increasingly stricter national measures are being implemented to protect public health. The health and well-being of our colleagues, clients, friends and families are our first priority

 

Please be advised. QAdvis will to the outmost extent support our clients and deliver according to plans. We strive to offer all our services with unchanged capacity and quality. The situation will however lead to an increase of solutions where more remotely work and communication will have to be done. We hope you will understand and respect this decision.

 

In order to eliminate any risk of QAdvis hosted events or QAdvis employees becoming a source of risk for clients and colleagues, we have decided to offer our courses and breakfast seminars remotely for March and April 2020. Breakfast seminars presentations are as always also possible to download afterwards.

 

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.
All of us can of course be reached by phone, e-mail, website as always.

 

Information will be updated continuously on our website. Don’t hesitate to contact us on info@qadvis.com

 

Stay safe and healthy.
Best regards

 

Nils-Åke Lindberg
CEO

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).