Quality management

Quality Commitment AnatomikModeling

AnatomikModeling relies on 10 years of R&D with the Toulouse University Hospital and 10 years of activity with more than 300 surgeons to develop safe and effective custom-made medical devices.

Each implant we design is a precise response to a unique need, drawing on our extensive medical expertise, strong experience in medical device design, choice of reliable partners, and the rigor of our processes, as demonstrated by our ISO 13485:2016 certification.

Our expertise in 3D medical device design

With nearly 2500 cases of custom-made 3D implants designed, we have acquired unique expertise in medical device design for:

  • thoracic deformities such as Pectus Excavatum and Poland Syndrome,
  • calf and upper limb atrophies,
  • cranial vault malformations,
  • airway obstructions.
AnatomikModeling expert working on a 3D implant model

Our strengths:

  • our engineers, with solid training and extensive experience, supervise each project, ensuring the mechanical and biomedical consistency of the design and aiming for the best morphological results,
  • each design is reviewed by our medical expert and then validated by the responsible surgeon, taking into account the specificities of each case and the particular precautions to be taken during surgery,
  • we use the best medical data processing software for anatomical segmentation and 3D design, resulting from over 20 years of continuous R&D. We are also gradually integrating artificial intelligence tools to optimize our modeling processes.

 

Our medical foundation & expert network

AnatomikModeling was created to develop the original concept of custom-made 3D implants invented by Professor Jean-Pierre Chavoin, former head of the plastic surgery department at the Toulouse University Hospital and General Secretary of the French Society of Plastic Surgery for 15 years. With over 800 cases operated on over 20 years, Professor Chavoin is now President of AnatomikModeling and brings his unparalleled medical expertise on a daily basis.

Prof. Chavoin training surgeons on 3D implant technique

Our medical expertise:

  • ongoing medical publication activity on custom-made 3D implants and personalized tracheobronchial stents in leading international scientific journals (bibliography),
  • participation in national and international congresses in plastic, thoracic, pediatric surgery, and pulmonology to promote the technique and exchange with top specialists,
  • regular organization of webinars and workshops for healthcare professionals,
  • personalized training of recognized surgeons in their specialty to ensure adherence to meticulously described surgical protocols,
  • management and follow-up of our network of over 170 referral surgeons, involvement of the most active surgeons in continuous improvement and worldwide dissemination of the technique,
  • expert medical support for each new case, with patient file reviews, clinical discussions, and design optimization based on the planned surgical procedure.

Our choice of manufacturing partners

The quality of our custom-made devices also relies on the choice of our manufacturing partners. We collaborate exclusively with ISO 13485:2016 certified legal manufacturers meeting the highest standards of the medical device industry defined by European regulation (MDR 2017/745):

Our partners share our requirements in traceability, quality control, and material safety, and have proven expertise in medical device manufacturing. This chain of trust ensures that each implant designed by AnatomikModeling is manufactured in a controlled environment, compliant with international standards, and ready to meet the expectations of both surgeons and patients.

 

Our ISO 13485:2016 Certification

An international recognition of our quality commitment

ISO 13485:2016 Bureau Veritas Logo

AnatomikModeling is ISO 13485:2016 certified by Bureau Veritas Certification. This major milestone officially recognizes the rigor of our quality management system, aligned with the most stringent requirements of the medical device sector.

"Since the creation of AnatomikModeling, we have developed, optimized our modeling processes and conducted intensive R&D (over 2500 cases), which enabled us to comply with ISO13485:2016."

ISO 13485:2016 is the reference standard for quality management systems applied to medical devices. It guarantees:

  • process control ensuring data and product traceability and safety,
  • regulatory compliance with international standards,
  • rigorous risk management throughout the product lifecycle,
  • reinforced trust with our industrial and healthcare partners.

A certification focused on our core business

The scope of this certification covers all our activities:

"Processing of medical data, modeling, manufacturing, subcontracted for the manufacture of custom-made medical devices."

It validates our ability to offer custom modeling services that meet both the specific needs of patients and the regulatory requirements of medical device manufacturers.

Since our creation, we have placed innovation and precision at the service of personalized medicine. This certification strengthens our positioning as a reference player in custom medical device modeling, closely aligned with each patient’s anatomy, for the treatment of complex conditions: Pectus Excavatum, Poland Syndrome, muscle atrophies, tracheal stenoses...

View our certificate

Measurable results, shared trust

Satisfaction and trust from referring surgeons

The recognition of our quality commitment is reflected in the satisfaction of our patients and surgeons.

A study published in Plastic and Reconstructive Surgery reports an 80% patient satisfaction rate after correction of Pectus Excavatum with a custom-made 3D implant as indicated in the Plastic and Reconstructive Surgery journal.

From the practitioners' perspective, our internal surveys reveal:

  • 95% satisfaction with the quality of designs and design discussions
  • 97% satisfaction regarding our medical support (professional documentation, training, and Prof. Chavoin’s personalized expertise)
  • 97% satisfaction regarding our marketing support (website for patients and surgeons)

These figures confirm our commitment to placing excellence, reliability, and education at the heart of our approach.