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Clinical evaluation and clinical trials for medical devices

Events we speak at Posted by PeterPosted on Nov 04, 2020 21:59:05

Need to know more on what to do in this area? Join this coarse that Peter Löwendahl speach about risk management and the regulation around this. https://www.lakemedelsakademin.se/produkt/klinisk-utvardering-och-klinisk-provning-pabyggnadskurs-medicintekniska-produkter-2/



PRRC

Events we speak at Posted by PeterPosted on Nov 04, 2020 21:54:36

Check out this course Peter Löwendahl having That you can to learn everything about what this means for you! https://www.swedishmedtech.se/News.aspx?f_id=157824



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.



FDA latest guidelines

FDA/USA related Posted by PeterPosted on Oct 12, 2019 14:56:52

FDA have many guidlines and are outnumbering EU competely!
They have a page that also lists the latest guidelines in case you noticed one in the news flow but not find it when you search. Use the following link



MDR guidance documents

MDR/EU related Posted by PeterPosted on Oct 12, 2019 14:47:06

Often I get the question about where to find MDR/IVDR guidance document. Even though e.g Google or Bing search engines should get you there I post the link here to make it easier to find. https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en



Upphandlingskonferansen 2020

Events we speak at Posted by PeterPosted on Oct 12, 2019 14:39:34

25-26 mars 2020 är den stora upphandlingskonferensen som Swedish Medtech anordnar tillsammans med några andra organisationer. Peter Löwendahl tillsammans med Läkemedelsverket kommer att ha workshops gällande MDR och bland annat ta upp hur upphandling påverkas av eventuell brist på anmälda organ. Mer information kommer när programmet är slutligen satt.



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