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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

Regulations around the world

Regulatory Affairs Posted on Mar 03, 2019 12:59:15

We often get questions on what requirements there are in certain countries. Not that easy to answer since this clearly depends on what product you have! What we know for sure there are changes ongoing all the time. To much regulations will have negativ effect on the average health index in the world, and small vountries might not even get any manufacturers entering the market. WHO publish reports about regulations on an overall level. The latest we know about are from 2016. The below picture can be found there, explaing what out of 3 main factors exist in the country.

Läkemedelsverket Inspection strategy 2019

Regulatory Affairs Posted on Feb 27, 2019 08:54:40

Every year, normally in December, the Swedish authority are giving out a dokument explaining on how they do inspections and follow up of products in the marketplace. Overall the document explains how they work nationally and internationally both within EU but also with e.g. IMDRF countries. This gives a good picture on how authorities work together and what you can expect if you get into trouble in terms of information sharing across the world.The latest follow up document can be found here (in Swedish). The follow up report for 2018 is expected in late Q1.

The latest Inspection plan for 2019 can be found

And the latest follow up report from 2017 can be found