blog
Software as a Medical Device Regulated by the US FDA
Artificial Intelligence has achieved major milestones in the US, with the FDA granting clearance to the first AI-based software for…
blog
Digital Health Series: Defining Software as a Medical Device
Recently, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has provided updates to the guidance Software and AI…
whitepaper
Are Registries the New “Gold Standard” ?
There are multiple definitions associated with a registry and any future sponsors can feel anxious when it is time to…
webinar
What are the reimbursement pathways for innovative digital health technologies?
Innovative digital health solutions are finding their ways into routine patient care in the US and Europe, and different payers…
webinar
Entering US market: FDA’s consideration on digital health technologies
VCLS is glad to organize this virtual event with the Innovation Center Denmark in Boston in collaboration with Welfare Tech…
blog
New FDA Guidance on Multiple Function Device Products & Its Impact on Software as A…
While the original Apple Watch was a genuine consumer product with fitness tracking and health-oriented capabilities, the adjunct of the…
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…
