Munich software company, Climedo Health, has published a survey about the costs of EU MDR.
The objective of the survey is to find out more about the financial and time resources that medical device manufacturers are currently having to invest to manage the new regulation’s demands. Upon request, participants can receive the results as well as an anonymous comparison to other companies via email.
The survey will consist of 15 questions, and will focus on areas such as:
- Time investment
- Financial investment
- Communication with stakeholders
- Personnel and training costs
- The degree of automation within PMS and PMCF activities
- Current solutions for clinical data capture
Climedo Health are offering participants who leave their email address the option to receive the final evaluation after the survey has been completed. They will also receive an assessment of how much time and money they could save by using digital solutions for their clinical data collection.
Veronika Schweighart, co-founder and COO of Climedo Health, commented: "The EU MDR requires major changes and investments from medical device manufacturers. But many companies are not aware of exactly how much is being invested here.
“For this reason, we would like to analyse the resources in more detail and offer manufacturers an overall picture as well as the opportunity to compare themselves to other companies.
“We also believe that many of these resources could be reduced by using automated, digital solutions and would like to highlight these potential savings.
“We’re looking forward to getting many survey responses from all over Europe as well as exchanging ideas with participants later on.”
The survey will run for four weeks and is now available to complete here. The results will also be presented in a webinar by Climedo in September.