INTRODUCTION

PROFILE

QUALITY SYSTEM

R&D TECHNOLOGIES



NORAKER is located in France in the Rhône-Alpes region. NORAKER is committed each day to innovation in the fields of orthopaedics and dentistry, with the guiding principle of improving patient comfort.
As the specialist manufacturer of Bioactive Glass 45S5, we believe that every single patient in the world should profit from best-in-class medical technologies in the area of bone regeneration tissue engineering and regenerative medicine.

From scientific discovery and clinical trials to product manufacturing, we perform our research and innovation work with passion, producing in the end truly innovative technologies that make a real difference in the field of human health.

We know that a better smile, better speech, better health – even the simple ability to live normally – can dramatically improve a person’s life. Providing a high level of care enhances the patient’s quality of life, and the clinician’s professional reputation. For NORAKER, patient care represents a long-term commitment, to healthcare professionals and to their patients.

Excellence


Since its foundation in 2005, NORAKER has been specialised in the design, production and marketing of synthetic and bioactive biomaterial-based implantable medical devices for bone substitution and osteosynthesis. The medical devices offered by NORAKER cover an extensive range of applications:
- Orthopaedic field : spine surgeries, traumatology and cranio-maxillo-facial,
- Dental surgeries.



French technology


NORAKER chose local partners and French notified body (LNE/G-MED) to develop its products. NORAKER think ensures proximity to customers product quality and responsiveness.
NORAKER think proximity ensures to customers product quality and reactivity. Due to the high quality requirements and advanced technology, NORAKER is attentive to its users' needs and to patient comfort.


Patented Technologies


On the back of a multidisciplinary R&D team and an extensive trademark and patent portfolio, the business has set up the technical and human resources required to develop innovative products based on pure or processed bioactive glass.


NORAKER, attentive to its patients


The company has successfully set up regular close cooperation with professionals healthcare in order to meet the expectations of a demanding market, with a single common objective :improve patient comfort.





The products developed by NORAKER belong to the category of Implantable Medical Devices pursuant to European Directive 93/42/EEC amended by directive 2007/47/EEC.

The company's industrial credibility routinely involves monitoring a comprehensive and thorough quality system compliant with NF EN ISO 13485 (specific for medical devices). NORAKER was awarded NF EN ISO 13485 certification in 2008 and which was renewed in 2011, 2014 and 2018 with LNE/G-MED like notified body.

All NORAKER products have been awarded the CE mark by LNE-G-MED, guaranteeing compliance with European production, traceability, safety, labelling and packaging specifications.

Due to the high quality requirements and advanced technology, NORAKER is attentive to its users' needs and to patient comfort.





NORAKER has built its growth on a strategy of differentiation through innovation, particularly based on the use of bioactive glass in the design of its bioactive medical devices.




Intellectual property


NORAKER's R&D projects relate both to biomaterial development and to associated production processes. It is through its research projects and development, NORAKER patents innovative technologies.

Due to its expertise, based on its know-how in bioactive glass synthesis and processing, allows it to participate in numerous collaborative projects of national and European scale.

Partnerships with institutional and academic organisations give the company the opportunity to benefit from knowledge in plastic technology, biological tests, biomechanics, etc.
NORAKER works closely with a scientific consulting firm made up of surgeons recognised in their specialised field, to develop medical devices adapted to market expectations with a single end purpose: improving patient comfort.


R&D is focused on the development of new bioactive products in order to access new applications. Due to its expertise, based on its know-how in bioactive glass synthesis and processing, NORAKER is a specialist in bone substitution.