Navigating Medical Device Certification - Innovator Perspectives

The world of Medical Device Certification can be extremely complex and difficult to navigate. At ORCHA, we are keen to understand the experiences and perceptions of digital health innovators navigating the medical device certification process, particularly for Software as Medical Devices (SAMD). 

We would like to speak to digital health innovators who have developed native health-apps and have either i) successfully applied and achieved Medical Device certification ii) have applied for Medical Device certification but were unsuccessful, or iii) are currently, or soon to be applying for Medical Device certification for their digital health innovation. 

This short survey should take no longer than 10 minutes to complete. All responses will be made anonymous with the exception of any email addresses provided for those willing to be involved in a future interview or workshop around their experiences of navigating this complex space. 

Insights gathered from this survey will help ORCHA to simplify the process of navigating the medical device regulation process, making it more transparent and hopefully less costly, for both current and future innovators.

If you consent to participate in this anonymous survey, please select 'yes' from the options below.