lowendahl.eu - News and information

Today Peter Löwendahl talked about MDR and experiences regarding CE marking of apps at the biggest Health IT conference in northern Europe.

The conference is an annual conference held in Gothenburg, Sweden

Peter Lowendahl featured in the Medtech Magasin. Read the article here.

Den 18 oktober håller vi årets sista PRRC utbildning som är riktade till alla som är eller planerar att bli PRRC. Utbildningen hålls tillsammans med Swedish Medtech. Läs mer och anmäl er här.

I en serie av två utbildningar i samarbete med MTF får ni en genomgång av PRRCs ansvar i samband med specialanpassade produkter. På plats i Gävle 2-3 oktober samt en online 25-26 oktober. Läs mer och gör din anmälan här.

Utbildningarna vänder sig till alla organisationer som gör specialanpassningar tex hjälpmedel, tandläkare, sjukhus och regioner och kommuner.

We will participate and speak at Swecares annual meeting April 27, 2023. Read more avbout it on this link.

One againg our Peter Löwendahl visited the Medtech podd to discuss what the decided changes in IVDR and MDR means in practise. Will it help, what to look out for, key dates etc. Peter also gives his view on current climate for medtech manufaturers in EU and compare with the US market. The podd can be e.g. found at Spotify, search for ”medtechpodden” or klick here to get to Podbean.

We will be talking at the regulatory summit March 30, 2023. This time on three different subjects including beeing the moderator for one of the track.

read more here.

We will talk at the conference called steriledays. This association gather people working with sterile products in Sweden. UDI and he future will be the topic ae have been asked to present. Find the agenda here.

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

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.