blog
New Guidance on Clinical Evaluation of Medical Device Software
The Medical Device Coordination Group (MDCG) recently published a new guidance entitled “Guidance on Clinical Evaluation (MDR) / Performance Evaluation…
webinar
Medical Device Software Development: How to Build your EU/US Strategy
This webinar helps developers of e-health/m-health solutions to better understand the regulatory environment relevant to their digital technologies in Europe…
Case study
Creating a Regulatory Strategy for Software as Medical Device
A mobile diabetes software app for patients with diabetes to assist them in the management of their disease by monitoring…
webinar
FDA Consideration for e-Health
Anastacia Bilek, Ph.D. will share her experience in the regulation of m-Health products as a guide for product developers. She will…
webinar
Development and Registration of m-Health Technologies for the EU Market
e-health technologies are already today starting to revolutionize the therapeutic processes and patients management paradigm. Unfortunately, e-health developers are very…
publication
Telemedecine and e-Health Systems
A long-standing challenge for regulators has been how to incorporate new technologies into the current regulatory framework. This is especially…
presentation
Navigate the maze of MDR for Medical Device Software
This presentation is aimed at helping developers navigate the development and regulation maze of MDR for medical device software. Some…
whitepaper
Navigating the Maze of m-Health Regulation and Development
The widespread adoption of mobile and wireless technologies, including smartphones and tablets, has given rise to the growing field of…
