Efficiently meet regulatory requirements
REFeR-RYTHMO enables you to ensure long-term prospective monitoring of the safety and performance of your medical devices. Our network facilitates the collection of real-life clinical data and supports you in accurately assessing the benefit/risk ratio throughout the product life cycle, thanks to the recognized expertise of its members in post-marketing follow-up.
Our expertise
Our experts can provide advice at each of these phases:
- Design and management of post-marketing studies: protocol writing support, choice of design (observational studies, registries, databases), statistical analysis plan and performance indicators, regulatory support.
- Clinical data collection and active management: (E)CRF and database, traceability of serious adverse events and materialovigilance.
- Real-life clinical studies: data from healthcare warehouses (EDS) and SNDS, statistical analysis and results reporting
- Targeted clinical material-epidemiology study and registry: creation of ad hoc or national registries, multicenter field surveys, targeted and enriched data collection (clinical, technical, quality of life), patient involvement
.
Our key benefits
Based on the expertise of 18 clinical departments, 4 CIC-ITs and 2 IHUs, the network guarantees rigorous support rooted in hospital clinical practice.
- Regulatory support and data security.
- Clinical and methodological expertise.
- Tailored support for your projects.
Device safety management and reporting
Post-market follow-up is an ongoing regulatory obligation (MDR 2017/745 EC, Article 61, Annex XIV). REFeR-RYTHMO can help you with this follow-up.
[Find out more on the Context & Regulations]
Typical support path
REFeR-RYTHMO brings together 17 partner establishments involving 18 clinical departments, 4 Clinical Investigation Centers - Technological Innovation (CIC-IT) and 2 University Hospital Institutes (IHU Liryc).
👉 To discover all the network members: see the Member mapping
page.
Contact & first exchange
Do you have a project, an idea or need some advice?
We offer a free initial exploratory exchange to assess together the relevance of an accompaniment.
📩 Take contact our team or fill in the project form.
