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Rergulatory resources

Here more information and documents will be posted in the future

EU - MDR, MD, LVD

Do you know what to do with the new MDR, IVDR and bordeline products

Rest of the world

Many areas are complicated!.

Mobirise

USA - FDA, FTC, NRC

USA is a huge market, but there are many things you should know to be there long term.

China and Japan

The two most regulated countries in the world!

Mobirise

What to do

Strategy is important

Start where you are

We offers several ways to look into what is best for you. Using our partners in different countries

Easy and Simple to Use

We are here to help you!


NEWS

Listen to us

June 4, 2019

Event

We speak at an event about optimizing your business development för medical devices and how to secure that yo meet the regulatory requiremnts and use it for your own adventage.

March 19, 2019

Event

We speak at a breakfast seminar about software as medical device and the effect the new
rule 11 will have on software manufacturer. 

November 7, 2018

Event

We speak at "Upphandlingskonferansen"


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