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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