MedTech
As part of an ISO 13485-certified organization since 2018, we specialize in high-precision medical components. Our skills enable us to offer a complete service, from co-development to series production. Regulatory compliance and traceability guaranteed!
We do more than manufacture parts, we secure the micromechanical functions of medical devices.
Our approach: guaranteeing functionality and the aesthetics of your product!
From 0.2 to 42 mm, with a precision of the order of a few microns and surface finishes from component to function!
Waterproofing
Features
Application of developed protocols
with customers for sealing validation
Transmission / Reduction
Features
Form and tooth machining for
guarantee functional transmissions
Cutting / Suturing
Features
Sharp edges or sharp points for
surgical application
Mounting / Clipping
Features
Adjustments for axial holding, torque holding,
clipping forces
60m2 clean room
30 CNC machines
100,000 machining hours / year
Technological tools and industrial capacity in ISO 13485 environment
A wide range of microtechnical know-how is part of a industrial organization ISO 13485 certified to offer a complete service
Full service: One stop shop and Contract Design Manufacturing Organization model
Design for manufacturing
Project management, cost optimization and technical feasibility analyses thanks to a robust product definition. FMEA helps identify risks and ensure reliability before prototyping.
Prototypes
Production of the first examples to validate feasibility and performance, and define preventive actions to guarantee product reliability.
Industrialization qualification
First production runs using production resources to validate the industrial process. This stage includes equipment qualification (IQ/OQ/PQ), process capability analysis (Cpk, Cmk) and the creation of quality files (PPAP, FAI, technical file) guaranteeing product and process conformity.
Production - scale up
Move to series production with controlled volume ramp-up, guaranteeing repeatability, conformity and on-time delivery.
Accelerate your time to market with ONE ISO 13485-certified microtechnology partner
Simplify the development and reliability of your medical devices with confidence and security
Expertise and solutions
Building on experience acquired since over the decades, we have developed expertise in a wide range of medical disciplines: for applications implantable, invasive or non-invasive, here are just a few examples.
Hand-held components and assemblies
Dental
Suture anchors
Instrumentation system
Orthopedics
Components for surgical robots
Catheter-mounted ablation and repair components
Needles and cannulas
Surgery
Connectors for implantable chambers
Diagnosis and treatment
Case
applications
The heritage of watchmaking assembly technology for medical applications
A riveting technique mastered from design to industrial production, and based on the Group's watchmaking expertise, the solution implemented for our customer has delivered the safety expected of a medical device.
More than just an implantable connector, guaranteed leak-tightness and special test protocols
An implantable medical device includes a stainless steel connector with a particular geometry, the purpose of which is to guarantee a leak-tight seal. Our machining solution, with integrated leak-testing protocol in production, ensures the required function!
A turnkey industrial solution including 3D metrology control protocols
For a portable medical device for diagnosis and treatment, we developed and qualified a repeatable measurement method that secured not only production but also the complete qualification of the device and its functionality.
Microtechnology and industry, rigor, care and precision
Heirs to the watchmaking know-how we developed for medical applications, over 110 years of history and technological evolution have shaped our expertise.
Read the technical challenges is an integral part of Azurea's DNA!
Materials (bio-compatible)
Stainless steels.
1.4542 / 1.4441 / 14112
Titanium
Grade Nb / 2 / 4 / 5
Plastics
PEEK / POM H
Complex geometries
Machining 5 axes and control
three-dimensional metrology
Care and integrity
The rarest beauty is always the most fragile. Handling, washing and packaging are carried out with the appropriate care
From millimeter to micron
Historically, we have been involved in the production of small components; the tolerances of the a few microns are part of our daily lives.
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