International Clinical Evidence Professional Society, the global leader in the development of innovative approaches to evidence harmonization for medical devices and in-vitro diagnostics.
Meditrial
https://www.meditrial.net/
intouch@meditrial.net
+1 (800) 901-4286
https://www.linkedin.com/company/meditrial-today/
About Meditrial
Meditrial is a global medical device clinical, regulatory and market access organization supporting manufacturers throughout the entire product lifecycle.
With operations and expertise across Europe and the US, Meditrial combines deep medical device regulatory and clinical research expertise with technology-enabled solutions to help manufacturers bring innovative products to market and generate the evidence needed to support their continued development and access.
What distinguishes Meditrial is the combination of hands-on operational experience, regulatory expertise and active contribution to the evolution of the medical device regulatory landscape. Our team does not simply interpret existing requirements for clients; we are actively engaged in international initiatives, standards development and scientific programmes that contribute to shaping the future of clinical evidence and medical device regulation.
What they do
Meditrial provides integrated clinical, regulatory and market access solutions for medical device and IVD manufacturers.
Our services span the full medical device lifecycle, including clinical investigation strategy and management, clinical evaluation and evidence generation, regulatory submissions and representation, post-market clinical activities, vigilance and regulatory compliance, market access, and data and technology solutions.
Alongside our consulting and CRO capabilities, Meditrial has developed its own digital solutions and technology platform, supporting the management of clinical and regulatory activities and enabling more efficient, controlled and data-driven processes.
Our expertise extends across the major international regulatory frameworks,including the EU MDR and IVDR, UK and Swiss requirements, and US regulatory pathways.
Importantly, Meditrial also contributes to the development and evolution of the frameworks themselves. Through the scientific and regulatory leadership of our team, including our Medical Director and CEO Monica Tocchi, Meditrial participates in initiatives addressing emerging regulatory and clinical evidence needs, including work related to ISO 14155, ISO 18969, the EU MDR and innovative approaches such as the HEU Early Feasibility Study (EFS) programme.
This combination of implementation expertise and standards development allows Meditrial to bring clients both practical experience and a forward-looking understanding of where the regulatory environment is heading.
Why choose Meditrial
- Meditrial understands the scientific and regulatory rationale behind clinical trial requirements and regulatory pathways and how the regulatory landscape is evolving.
Our key differentiators are:- Medical device specialization: our expertise is focused on medical devices and IVDs, rather than being diluted across multiple life-science sectors.
- End-to-end capabilities: clinical, regulatory, quality, market access and post-market expertise can be integrated across the product lifecycle.
- Technology-enabled delivery: our digital solutions complement our expert services, creating more efficient, transparent and controlled workflows.
- International perspective: Meditrial operates across multiple major regulatory markets and understands the practical challenges of global device development.
- Regulatory and scientific leadership: our experts are actively involved in international standards, regulatory initiatives and programmes designed to address emerging challenges in medical device clinical evidence.
- A forward-looking approach: we do not simply ask, “What does the regulation require today?” We also ask, “What will good clinical and regulatory practice need to look like tomorrow?”
Why the support ICEPS
Meditrial supports ICEPS because we share the same fundamental belief: the future of medical device innovation depends on high-quality clinical evidence, international collaboration and continuous evolution of regulatory and scientific practice. As an organization working at the intersection of clinical research, medical device regulation and evidence generation, Meditrial sees great value in creating a forum where industry, clinical experts, regulators, researchers and other stakeholders can exchange knowledge and contribute to the evolution of the field. This is closely aligned with Meditrial's own approach. Through our leadership and scientific experts, we actively contribute to international standards and initiatives shaping the future of medical device clinical evidence and regulation, including ISO 14155, ISO 18969, the EU MDR and innovative programmes such as the HEU Early Feasibility Study initiative. Supporting ICEPS therefore goes beyond sponsorship. It is a way for Meditrial to contribute to a global professional community dedicated to improving how clinical evidence is generated, evaluated, communicated and ultimately used to support better decisions for patients and healthcare systems. We believe that organizations involved in generating and regulating medical device evidence have a responsibility not only to comply with today's requirements, but also to participate in the dialogue that defines tomorrow's standards. ICEPS provides exactly this type of collaborative environment, and Meditrial is proud to support its development.