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IVDR and implementation

Uncategorised Posted by PeterPosted on May 16, 2022 18:02:07

Our consultant Peter Löwendahl have been interviewed in the latest edition of Lifescience Sweden about IVDR and effects on the industry.

Read the article here



Reprocessing of single use devices

Uncategorised Posted by PeterPosted on Apr 05, 2022 19:18:27

Sweden have now decided to allow reuse of non reusable medical devices! The decision and requirements can be found here.

We think this decision is the wrong one to take and could hevily effect patient safety. The sterilization methods used for reprocessing are for many type of diseases not enough. Typical example we have seen and experienced in real life are CJD.



Är du PRRC – utbildning 5 april 2022

Uncategorised Posted by PeterPosted on Feb 09, 2022 12:38:21

Är du PRRC eller kommer att bli det enligt IVDR eller MDR? svarar du ja på den frågan är detta utbildningen för dig! Denna görs av oss i samarbete med Swedish Medtech!

Läs mer och anmäl dig här!



Regulatory Summit 2022

Uncategorised Posted by PeterPosted on Feb 09, 2022 12:33:42

This years Regulatory Summit is taking place March 31, 2022. We will speak in several sessions.

Read more about it in this link. The plan this year is to have a hybrid meeting with both online and at location!

Ensure to grab your seat Today to listen to many good speakers abut very urgent subjects!



Upphandlingskonferensen 16 mars 2022

Uncategorised Posted by PeterPosted on Feb 09, 2022 12:28:27

We will speak at this conference where buyers meets companies that provides medical devices!

Read more and secure your seat (zoom) here



View from todays training

Uncategorised Posted by PeterPosted on Oct 21, 2021 14:20:41



Artikel i Medtech Magazine

Uncategorised Posted by PeterPosted on Oct 19, 2021 15:07:11



Medtech Pod

Events we speak at, Uncategorised Posted by PeterPosted 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 by PeterPosted 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 by PeterPosted 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.



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