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Training for PRRC 28 September 2021 and 18 November 2021

Events we speak at, Uncategorised Posted by PeterPosted on Sep 15, 2021 20:00:40

In cooperation with Swedish Medtech we invite you to participate in this popular training. We will go yhtough all aspects on responsibilities, cover differences between countries and what to look out for. Ensure to get your seat reserved today through this link. This training will be online.



Day about PMS September 23, 2021

Events we speak at, Uncategorised Posted by PeterPosted on Sep 15, 2021 19:56:09

This seminar is about Post Market Surveillance. We will specific talk about how to meet the obligations in MDR and IVDR and not violate GDPR. For many manufacturer it might be a balance act to meet both at the same time. In the seminar the basic parts in the regulations will be reviewed and what you should think about!
Read more about the event and reserve your seat here. The seminar will be online.



Talk at AIDA day September 15, 2021

Events we speak at, Uncategorised Posted by PeterPosted on Sep 15, 2021 19:47:26

We talk at the AIDA days about MDR, effects on research and things to consider with AI products. AIDA is supporting research. Read more here.



Article in Digital Hälsa

Uncategorised Posted by PeterPosted on Apr 11, 2021 14:58:44

Peter Löwendahl was interviewed in the Swedish newspaper regarding Digital Health in Sweden. The article mainly covered software, MDR and Notified bodies.

If you want to read more about this, follow the link to Digital Hälsa



Hoff&Lowendahl AB in the news

Uncategorised Posted by PeterPosted on Dec 20, 2020 12:12:52

Hoff&Lowendahl has been named as one of the few companies in the region that have been able to drive both revenue, profit and hired people during the last year! Overall the workload for regualtory consultants have increased mainly due to IVDR and MDR says the CEO Lisa Lundström Löwendahl.



Rockstart talk

Uncategorised Posted by PeterPosted on Feb 27, 2020 22:16:19

On Tuesday the 25th February we talked for Medical Device startup companies that Rockstart Support. These companies are Mainly based in the Netherlands but also have Participating members in US and other EU countries



Medtechpodden

Events we speak at, Uncategorised Posted by PeterPosted on Feb 27, 2020 06:39:02

Now can you listen to Peter Löwendahls view of the regulation in a talk with the CEO of Swedish Medtech (in Swedish). Some of the key Problems is Walked through!



UK and what happens now

Uncategorised Posted by PeterPosted on Feb 16, 2020 20:34:18

Currently EU and UK sorks on the rules for leaving EU. In practice this means that UK follows EU rules until 31 December 2020. What the new rules will be is not know currently. This also. means that UK notified bodies will exist until that date easing up some of the burdon for the rest of Europe. Suggestion to go into MHRAs webpage and check status now and then. Also good to check what the Travel requirements Will be in case you want to spent new year in UK. Easy to get in but might be harder to get out!



Event we talk at 2020

Events we speak at, Uncategorised Posted by PeterPosted on Feb 16, 2020 20:00:07

Busy times and the need for information is high. Currently Peter Löwendahl is scheduled to talk at:

AI in healthcare Gothenburg February 6
Regulatory summit Stockholm February 20
Rockstart, Netherlands February 2

Affärsutveckling medicintekniska produkter Stockholm 11 mars

Upphandlingskonferensen 2020 Stockholm 25-26 mars



Hoff &Lowendahl signs agreement with Sensely

Other, Uncategorised Posted by PeterPosted on Jan 16, 2020 20:21:29

Hoff & Lowendahl have Signed an agreement with Sensely to be authorised representative in EU. Sensely are a manufacturer of AI based software for guiding patients In helathcare settings based on symptoms.



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