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Rockstart talk

Uncategorised Posted 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


Events we speak at, Uncategorised Posted 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 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 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 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 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 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.

Upphandlingskonferansen 2020

Events we speak at Posted 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.

The new software guidance for MDR/IVDR

MDR/EU related Posted on Oct 12, 2019 07:49:18

Finally the guidance came. A few intresting calls and even surprises in the examples. Read it yourself to ensure that you got it right! The guidance can be found  at

Regulatory summit 2020

Events we speak at Posted on Oct 05, 2019 20:33:55

February 20, 2020 the next regulatory summit will be in Stockholm. Stay tuned for program, or suggest direct here on what you like to hear mor about!

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