Dr. Isabella Steffensen

Dr. Isabella Steffensen is a biomedical scientist and President of Thera-Business Consulting. Over the past 20 years, Dr. Steffensen has assisted pharmaceutical and medical device companies with technical, regulatory, marketing, and business development issues. She has extensive experience preparing clinical evaluation reports and other regulatory documents, as well as other evidence based-reports such as practice guidelines and systematic reviews.

Recent Posts

Want MDR-Ready Literature Reviews? Start Here.

By Dr. Isabella Steffensen

*This post was updated in April 2020 to reflect the postponement of the EU MDR deadline.

Fun fact: did you know that the word “literature” appears approximately 30 times in MEDDEV 2.7/1 rev.4?

If you’re involved in the preparation of Clinical Evaluation Reports (CERs), you are likely beginning...