Entries by Johnnie Dahlberg

Finally, summer vacation!

During the late spring, the time for summer and for vacation can feel far away. But one thing is certain, it will always arrive and finally, now is the time to wrap up the first 6 months with a few words. The medical device industry has been home to some of the most revolutionary innovations […]

Gardening – Just like a medical device registration, it needs to be maintained!

Everyone who has a garden knows that the work in the garden is never done. Even if you have done your landscape planning according to the least burdensome approach, planted all the right plants and designed in perfect pathways, there will still come a day when your maintenance work starts. The situation is the same […]

Regulatory requirements are a design input.

What is the purpose of developing a medical device? If you ask your employees, the probable answer is that it is to help patients and fulfill user needs. Which is fair enough, but in order to do that we also need to understand that regulatory and government authorities also are included in the “user needs”. […]

Welcome to us Kecke Elmroth

With a solid background from Medical Affairs in MedTech industry and academic Life Science research, Kecke is skilled in clinical/scientific reading, writing, and interpretation. She is well-experienced in clinical evaluation, post-market clinical follow-up, clinical evidence gap identification, systematic literature search, and claims substantiation for regulatory purposes. Kecke is used to provide Medical Affairs input to […]