Market access for your
Medical Device

Chart the path of your
healthcare innovation

Rumb,

is the leading figure to guide you through the CE marking process
and international market entry. Our team combines business expertise to support healthcare, e-health and medtech entrepreneurs in the development
of their medical devices with both pragmatism and creativity.

Creativity

We identify innovative solutions and tailor
our approach to meet
your specific needs.

Agility

We adapt to your environment with flexibility, maintaining strategic, operational
and human continuity throughout your project.

Authenticity

We embrace your project
by offering solutions that meet your expectations and comply with regulatory requirements.

Steering your stride

Expertise and support

Strategic diagnostic

Define the product life cycle

Scope

Define the normative and regulatory requirements
of your project (according to your geographic scale)

Strategy

Set up an action plan to comply your product's development with the regulatory requirements.

Schedule

Set goals and deadlines for your regulatory
and clinical market access strategy

Tailored
Reliable
Diagnostic stratégique
marché des dispositifs médicaux

Bringing medical devices to market

Hoist the sails

Quality Management System (QMS)

Building your QMS and helping you structure your organization

Regulatory Affairs

Drafting of technical documentation for submission to a notified body and audit.

Clinical affairs (CRO)

Specification and construction of clinical evaluation guidelines, state-of-the-art analysis and clinical investigations.

ISO13485 (CE)
IS014971, IEC62304, ... (CE)
ISO14155 (CE)
ISO20916 (CE)
21 CFR 820 (FDA)
510K (FDA)
PMA (FDA)
...

Remaining medical devices on the market

Holding the line on compliance

Continuity

Post-market surveillance

Monitoring

Certifications renewal

Update

Normative monitoring

Tailored
Reliable
maintien sur le marché dm

We help project leaders anticipate and manage the risks associated
with the development
of their innovation.

We ensure useful
and secure innovations
to meet users' needs.

We facilitate the setting up and maintaining compliance
of medical devices with the applicable regulatory requirements.

We identify key deadlines
to ensure a confident entry into the market.

We manage deadlines
by setting realistic objectives
and assigning the right resources.

We bring together
the expectations of the entrepreneurial, financial, shareholder and mercantile industries.

Rumb, your local partner

A cross-disciplinary team to meet all your project needs

+20people involved
1specialized ecosystem
100%adapted to your project

Navigating together

Among our clients...

Gael_Constancin_ivirtual.png

Rumb has played a key role in the development of i-Virtual,
especially regarding aspects linked to clinical studies
and the implementation of a quality management system.
Our young company was able to rely on a competent and dynamic team, which enabled us to tackle the CE Medical Device class IIa certification process in the best possible conditions, for a particularly innovative SaMD technology
that had never been certified before.

A particular highlight is the efficiency
and speed of the clinical trial process.

Gaël Constancin - CEO i-Virtual

You have a e-healthcare or medtech project?

Let's talk about it.

FAQ

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