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Strategi- och affärsutveckling för life science-ledare 20-22 oktober 2021

Uncategorised Posted on Sep 24, 2021 19:24:01

I den här 4 dags kursen får ledare möjligheten att gå igenom allt från ax till limpa för ett företag. Vi kommer att föreläsa om och ha grupp arbeten runt de strategiska valen för medicintekniska produkter och hur man kopplar detta till den kliniska planen.

Fullständigt program hittar ni här. Men skynda att anmäla er, bara någon enstaka plats kvar!



Latest IVDR pod

Uncategorised Posted on Sep 24, 2021 12:16:30

You can listen to the podd here. In this Podd Anna (CEO) at Swedish Medtech and Peter Löwendahl talks about the IVDR regulation and challenges for manufacturers to meet the requirements in time!

As stated before our view is that IVD companies need to get one more year to be able to get hold of a Notified Body.



Medtech Pod

Events we speak at, Uncategorised Posted on Sep 20, 2021 19:10:48

Swedish Medtech have several podds about medical devices in general but also a few specfic ones discussing the new regulations with Peter Löwendahl from Hoff&Lowendahl. These can be found here. Today we recorded a new Podd that will be released soon!



Clinical evaluation training November 9, 2021

Events we speak at, Uncategorised Posted on Sep 15, 2021 21:31:54

This 2 day course gives you deeper insight in clinical evaluation and clinical trials for medical devices. It will be online. Find out more about the course here.



Training for PRRC 28 September 2021 and 18 November 2021

Events we speak at, Uncategorised Posted 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 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 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 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 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 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



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