Quality and regulatory

Bring support for quality
and regulatory affairs

Certify your medical innovation in the best optimized and most secure way.
Tailor-made regulatory support

From research to market

Any type of structure

Laboratories, hospitals, project leaders, startups, leading companies, our offers are customized to fit any type of organisation, regardless of their size, objectives, and resources.

A diversity of innovative products

Implantable Medical Devices, electromedical, in vitro diagnostics, clinical decision support software, telemonitoring, and more! Our experience helps us assist you on various topics.


We can step in and assist you at any moment during the product certification cycle, regardless of maturity or need.

Strong expertise in software regulation

We support you on all topics pertaining to quality and regulation of medical devices, specifically on software (62304, AI, cybersecurity, telemonitoring, etc.).

flexible services

We offer services for all types of medical devices, including in vitro diagnostics. They cater to specific expectations and needs and can be activated independently from each other.

Regulatory strategy

The objective: providing for your product the optimal regulatory roadmap to access the European or American market. The strategy involves among other things the product classification, clinical claims, critical points to be wary of delays and certification costs.
Give credibility to your project at a regulatory level, support fundraising, bring clarity on your organization, roadmap, major milestones to be reached and necessary means.

Clinical investigations

We support you on product design and building of the regulatory file ahead of its submission to competent authorities (ANSM, CPP). Furthermore, our ISO 13485 certification helps us take charge of regulatory compliance for unmarked CE devices for clinical investigations.
Get help for your prototype design, delegate the regulatory manufacturer’s responsibility and jumpstart your clinical investigation!

CE/FDA market authorisation

Throughout the design and industrialization phases, we support you in ensuring that your deliverables reach the level of quality expected by the authorities. We review your technical files, assist you during submission and exchanges with the authorities. In case of product changes, we help you to update documentation and get necessary clearance.
Secure the development of your product and the granting of commercial authorization thanks to the assistance of our referenced experts.

Quality management

We assist you in setting up your quality management system (QMS), certified ISO 13485 or 21CFR Part.820.
Ensure that your QMS is the best suited for your type of structure, products and experience in the field.

Specific expertise

On top of that, we also intervene on various topics related to regulatory: training onspecific standards, audit of your activities according to the ISO 13495 or IEC 62304 standards, audit of your subcontractors and many more.

Standards of expertise

Quality management


Quality management

21 CFR 820

Risk management




Medical Device

2017 / 745 / CE

In vitro diagnostic medical
device regulation

2017 / 746 / CE






IA Act

Health software


device software




Active implants




Sterile packaging






Key figures

Our successes


CE markings


ISO 13485 certifications granted


clinical investigation authorizations granted
More than a contractor, a true partner

Our work philosophy


Resources allocated to your project are dimensioned based on your progress and upcoming milestones


We anticipate project sticking points and communicate with you early enough to ensure they are integrated in the global roadmap.

Transfer knowledge

Along the project, we train your QARA resources to ensure your full autonomy and the sustainability of the project.


We participate in your discussions with subcontractors, notified bodies and competent authorities to help you understand better the information gathered and provide answers to any question.

At your side

We value the human touch and thus intersperse remote work with visits on your premises at key moments of the project. We help you own the solutions implemented.
QARA expertise

Our strong points

An experienced team
Our team members come from various horizons and have a strong operational experience. They support you on regulatory and design challenges and leverage on lessons learned on technical issues or subcontractor management.
Varied expertise
Biocompatibility, sterilization, cybersecurity, telemonitoring, usability, artificial intelligence, process validation, etc. Our experts can assist in most of the challenges you may face.
Close ties between our software and regulatory teams
Our two departments work in close collaboration, allowing technical software experts to be involved in regulatory projects, and conversely.
Institutional recognition
Our consultants are referenced as experts by Bpifrance (public investments bank) and others institutions.
Delegation of manufacturer’s responsibility
A structure able to endorse manufacturer’s responsibility on your behalf for a clinical investigation through our ISO 13485 certification.
Customers & Partners

They trust us

Medtronic - Medicrea
Pelican Health
Moon Surgical
IHU Strasbourg
AGIR à dom
SATT Paris-Saclay

Learn more about

Our quality and
regulatory support

Do you have a project or specific need?
Let’s discuss.