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lowendahl.eu - News and information

IVDR and implementation

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



We speak at PLM forum October 21, 2021

Events we speak at, MDR/EU related, Regulatory Affairs Posted on Oct 20, 2021 12:38:47

Come and listen to us but also many other comeptent speakers at the 2021 PLM forum. For more details and how to secure your access, visit the event page!

The title of our presentation is – Wake Up and Smell the Coffee!

Learn more about the challenges posed by Medical Device and In Vitro Medical Device Regulations. Discover how to manage this additional regulatory complexity by improving product documentation. And at the same time make this to be your additional competetive edge



Artikel i Medtech Magazine

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



Egentillverkning IVDR och MDR 1 december 2021

Events we speak at Posted on Oct 19, 2021 12:24:30

Vad gäller för vårdgivares egentillverkning av IVD och medicintekniska produkter samt hur är tillverkarens syn på detta! Detta och lite mer kommer att disskuteras om på detta event där vi pratar om tillverkarens perspektiv! Tillsyns myndigheten för detta område IVO kommer även att delta! Läs mer och anmäl er här



Vi pratar på sterildagarna

Events we speak at Posted on Oct 19, 2021 12:10:04

To read more visit the website



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