Unique Excellence Hubs
Driven by scientific advances, regulatory reform, technological disruption and consumer demands, the Healthcare field is undergoing unprecedented transformation. Aligned with the emerging trends and customer needs, we launched our Unique Excellence Hubs in order to support our partners in addressing complex and challenging research questions.
PMCF Study Center
The EU MDR 2017/745 introduces more stringent requirements regarding the Post-Market Surveillance (PMS) system, calling for a defined Post-Market Clinical Follow-up (PMCF) plan to be included in the Technical Documentation.
The PMCF plan defines clearly the activities that are carried out following the CE marking of a medical device to proactively collect and evaluate clinical data on the safety and performance of a medical device within its intended use.
As stated in the ANNEX XIV Part B, “PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex and shall be addressed in the manufacturer’s post market surveillance plan.”
However, the lack of practical experience and specific guidance in selecting the suitable activity for your device may lead to confusion and inappropriate decision.
At Evidilya, we launched the unique PMCF Study Center in coordination with a network of European healthcare excellence units and professionals to determine the best PMCF strategy and design for your medical device balancing costs and benefits.
Microbiota Platform
The human intestinal tract hosts an enormous variety of microorganisms actively shaping human health, collectively called gut microbiota. It is estimated to be ∼1013–1014 microbial cells, with around 1:1 microbial cells to human cells ratio.
More and more research has been carried out to explore the role of Gut Microbiota and metabolites in several host’s physiological functions including metabolism, development and homeostasis of immunity and the nervous system.
Recently, new research has strengthened the fact that our Gut Microbiota is a key modulator of our mood and cognitive functions along the Gut–Liver–Brain Axis.
It has been unveiled the possibility of regulating the gut vascular barrier to reduce inflammation, ameliorate negative psychiatric impairments and empower cognitive functions.
At Evidilya, through our MICROBIOTA PLATFORM, we collaborate with EU and USA Centers of Excellence in Digestive Health and certified Microbiological and Metabolomics experts.
Our aim is to support Partners in exploring the Gut-Liver-Brain Axis’ role in health and disease, as well as its therapeutic potential: new gut understanding leads to new treatment opportunities.
