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.
Anytime
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.).
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!
Brain Computer Interface - CEA / Clinatec
Magia: MagIA© Produit non marqué CE
Braincam - Iconeus
Twim In Motion - Modjaw
Canule de trachéotomie sur mesure - SATT Paris-Saclay
Analyse du mucus - Rheonova
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
system
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
system
13485
Quality management
system
21 CFR 820
Risk management
14971
Usability
62366
Medical Device
Regulation
2017 / 745 / CE
In vitro diagnostic medical
device regulation
2017 / 746 / CE
FDA
510(k)
Cybersecurity
81001-5-1
Artificial
intelligence
IA Act
Health software
82304
Medical
device software
62304
Electromedical
60601
Active implants
45502
Biocompatibility
10993
Sterile packaging
11607
Sterilization
11135
Sterilization
11137
Key figures
Our successes
10+
CE markings
10+
ISO 13485 certifications granted
20+
clinical investigation authorizations granted
More than a contractor, a true partner
Our work philosophy
Adapt
Resources allocated to your project are dimensioned based on your progress and upcoming milestones
Alert
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.
Facilitate
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
Learn more about
Our quality and
regulatory support
Do you have a project or specific need?
Let’s discuss.
regulatory support
Do you have a project or specific need?
Let’s discuss.
