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.
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!
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!
We will speak at this conference where buyers meets companies that provides medical devices!
Read more and secure your seat (zoom) here
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!
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
