Rede Optimus
Turning Complex Medical Device Research Into Executable Studies

Medical device companies and investigators often begin with a clear clinical or product development objective, but turning it into a feasible study brings another level of complexity. The research must generate scientifically robust evidence, remain practical to execute and meet regulatory requirements. Early decisions around design, endpoints, submissions and site strategy can shape what follows.

“Medical device studies are rarely ‘one size fits all’,” says Marc Bosiers, CEO, Rede Optimus. “Regulatory requirements and operational realities can vary significantly between countries and sites.”

Rede Optimus brings clinical, regulatory and study management expertise together to turn complex requirements into executable studies. It has supported more than 140 clinical studies across over 20 countries. Its hands-on model keeps project managers and CRAs close to sponsors and sites. The company can manage a complete clinical investigation or provide individual services, with scope, milestones and fixed budgets agreed upfront.

Building the Study Around the Question

The work often begins before a protocol exists. An investigator may bring a clinical question without defined endpoints or an execution plan. Rede Optimus helps structure the idea by clarifying what the study needs to answer, which endpoints can generate meaningful evidence, how many patients and sites may be required and which regulatory pathway applies.

Industry-initiated research typically begins with product development and regulatory goals, while investigator-initiated research may need more support around concept development and protocol design. Collaborative research brings investigator insight together with industry device knowledge, funding and resources.

Once the direction is clear, Rede Optimus can develop the Clinical Investigation Plan, Case Report Forms, informed consent and monitoring documents. It can establish Electronic Data Capture, coordinate data management and statistics, manage regulatory submissions and support site identification, qualification and initiation through enrolment, follow-up, monitoring and close-out.

A project manager coordinates the sponsor, sites, CRAs and other functions. Progress, risks and issues are followed closely. When a problem emerges, the team assesses its impact and brings the sponsor possible solutions before it affects the wider study.

International Reach With Direct Involvement

That combination of scale and proximity matters in multicountry device investigations. Rede Optimus is involved in international studies across cardiovascular and peripheral vascular indications, including Class III devices.

In one recent cardiovascular investigation across several European countries, it supported country and site start-up, documentation, site training, monitoring and project oversight. Its team identified country- and site-specific differences early and worked directly with the sponsor and investigators to resolve them while maintaining consistency across the study.

“We are large enough to manage complex international medical device studies, but we intentionally maintain short communication lines and direct involvement from experienced team members and senior management when needed,” says Julie Bosiers, COO.

Evidence Across the Device Lifecycle

Rede Optimus also connects clinical research with regulatory affairs, reimbursement and post-market clinical follow-up. Early studies may focus on safety and performance, while later evidence must support the intended regulatory pathway. After CE marking, PMCF helps demonstrate continued safety and performance in clinical practice, while reimbursement brings healthcare systems and payers into the evidence strategy.

Its medical device specialization matters because approaches developed for pharmaceutical studies cannot always transfer directly to device research. Rede Optimus works with device-specific clinical, regulatory and execution requirements and can carry projects through clinical study reports and publication support where required.
Predictability is built into the commercial model. Rede Optimus uses fixed budgets linked to defined study milestones agreed upfront, giving sponsors visibility on expected costs, deliverables and key project stages from the outset. This milestone-driven approach creates shared accountability and keeps discussions focused on study progress, quality and delivery rather than continuously tracking billed hours.

Rede Optimus’ medical device specialization, international experience and direct involvement have earned it recognition as Top CRO Solutions in Europe 2026. Its approach keeps scientific, regulatory and execution decisions connected through close-out, helping sponsors and investigators move studies forward with clearer structure.