Archive



17. May 2022

New Opportunity to join the Effectum Team!

To further grow our company, we are looking for a

Junior Project Manager Medical Devices with Software Know-how (80-100%)

to join our team.

In this position

  • You will manage medical device and invitro diagnostic (IVD) medical device projects for our customers, which are start-ups and project teams from global players, for their EU & FDA registration and therefore play a key role in making their projects a success.
  • You will support our customers in bringing the technical documentation to the point where they can obtain the CE mark (or FDA approval). You will review, approve, and also write parts of the technical documentation.
  • Your main focus will be projects in medical software and active medical devices/ IVD with embedded software of all risk classes.

(more…)



02. May 2022

Interview for BioLago

In an interview for BioLago – the health network, our co-founder and CEO Karina Candrian talks about the typical challenges startups are facing when trying to bring a new medical device to market.

Karina for example highlights the importance to think about market access and regulatory issues early on. Ideally as soon as you have a suitable product solution. The intended use and properties of a product determine its classification, which in turn has a significant impact on the approval process, budget and time to market.

Read the interview with Karina (in German) on the BioLago blog.