STATICE SAS of Besancon at COMPAMED 2017 in Düsseldorf -- COMPAMED Trade Fair
OEM

STATICE SAS

9, rue Thomas Edison, 25000 Besancon
France

Telephone +33 3 81484343
Fax +33 3 81533523
commercial@statice.com

This company is co-exhibitor of
IVAM Microtechnology Network

Hall map

COMPAMED 2017 hall map (Hall 8a): stand F29

Fairground map

COMPAMED 2017 fairground map: Hall 8a

Our range of products

Product categories

  • 01  Components, parts, modules, Original Equipment Manufacturers
  • 01.39  Silicone components
  • 11  Manufacturing Services
  • 11.15  Extrusion
  • 11.15.10  Clean-room moulding
  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.15  Product design and development
  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.17  Prototyping

Our products

Product category: Silicone components, Microtechnology, Product design and development, Prototyping

LONG-TERM IMPLANTS AND SINGLE-USE DEVICES

Over the years, STATICE has shown and demonstrated their ability to design and develop a selection of long-term implants and single-use devices in classes I to III, in a number of industries ranging from neurology to cardiology and ophthalmology, ENT, obesity surgery, and others.
STATICE will remain close to you throughout the design and manufacture of your medical device, all the while considering the technical aspects or constraints together with the required specifications:

  • Selection and choice of biocompatible materials (silicon, bioresorbable thermo-plastics) ISO 10993
  • Procedures for the transformation of materials (LSR injection, plastic injection, extrusion, machining etc...)
  • Validation of any special requirements or conditioning (gluing, welding, clipsing etc...) and validation of required product performance
  • Ergonomics, facility of use
  • Application of all applicable Standards required and reference 93/42/CE.

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Product category: Silicone components, Clean-room moulding, Microtechnology, Product design and development, Prototyping

CLEANING, CONDITIONING, LABELLING

Cleaning
For devices that require sterilisation, STATICE suggests specific procedures depending on the devices or products with a range of facilities:
  • 70° ethanol and ultrasounds tanks
  • Ultrasound tanks with anti-bacterial and antifungal cleaning
  • Final cleaning with alcohol and wiping prior to conditioning in an ISO5 controlled environment.
The aforementioned procedures are validated depending on clients' requirements, and the associated testing and controls can be undertaken by Statice:
  • COT Total Organic Components
  • HCT Total Hydro-Fuels
  • LAL Residual Endo-toxins
  • (Bioburden) Initial Contamination
Conditioning 
STATICE has a range of thermo-sealants which enables conditioning the devices either in bags or in blisters.
 
STATICE applies the EN ISO11607-2 standards for conditioning goods, and guarantees the following procedures:
  • Leak testing
  • Peelability testing
  • Pull testing.
The cleaning and conditioning processes are done under the ISO5 standards.
 
Upon request, STATICE can provide further specific operational Quality Control conditions with regularly maintained and specifically designed equipment, and STATICE is able to provide all of the corresponding certificates for Quality of Installations.

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Product category: Microtechnology

CATHETERS AND ENDOSCOPES

STATICE has extensive experience in the design of innovative and technical endoscopes and catheters, with a diameter down to 3F depending on requirements or client specifications. The design and manufacture of catheters are all subject to the reference 93/42/CE.
The diagnostic catheters can have a variety of sensors or captors:
  • Electrical signals
  • Temperature
  • Pressure
  • Strength
  • Other specifications as required.
STATICE also specialises in active therapeutic catheters with electrodes or darts that ensure stimulation or ablation procedures.
 
These catheters can also be fitted with compliant, semi- compliant, or non- compliant balloons.
The design for catheters incorporates commonly used mechanical applications such as:
  • Kinking
  • Snaking
  • Torque transmission
  • Pinching
  • Soft tipping.
In order to reach the required Standards and quality depending on the clients' specifications, STATICE is able to assemble tubes with different diameters, materials, or multi-lumen, and can be reinforced or not.

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Product category: Microtechnology, Product design and development, Prototyping

ACTIVE MEDICAL DEVICES

STATICE is closely involved and committed to the production of regulated class I, II, and III electro-medical devices.
Our R&D team's expertise is essential for the complete development of any project, and includes:
  • Precision micro-technical skills
  • Piloting electronics (captors and activating technology)
  • Development of incorporated software
  • Development of man/machine interface systems.
The R&D department at STATICE will enable you to benefit from their continuous research into thermal regulation, UV emissions, micro-fluids, micro-outputs for gas, and integration of MEMS (Micro-Electro-Mechanical Systems)...
 
In applying the current regulations, CEI 60601, ISO 62304, and reference 93/42/CE, STATICE now finds itself in operating theatres, ICU wards, and in GP surgeries.

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Product category: Clean-room moulding, Microtechnology, Product design and development, Prototyping

ASSEMBLY OF CATHETERS AND ENDOSCOPES

With considerable experience in manufacturing catheters for electro-physiological treatment or ophthalmology, STATICE has developed quality know-how in assembling catheters.

STATICE develops, designs, and produces catheters in the following fields:
  • Electro-physiology
  • Ablation
  • Clinical data monitoring (neurology and others)
  • Endoscopy
  • Ophthalmology.
For specific applications, STATICE can produce and manufacture catheters with a diameter as low as 3F. A range of captors or sensors are available that respond to electrodes, pressure, temperature, force, and/or active components such as cameras, electrodes, or dart ablation can be incorporated.
The production of this type of catheters calls for complex and specific micro-technology processes which is where STATICE is a leader in the market:

Catheter welding between armed or simple tubing with different diameters
  • Tip forming
  • Coating
  • Micro-encapsulation of captors or sensors
  • Incorporation of electrodes or signal wiring
  • Incorporation of coudé catheter systems.
In order to respond to clients' specific requirements and the highest expectations of quality, STATICE is able to assemble tubes of different diameters, materials, multi-lumen, and reinforced or not: go to http://www.easy-cath-production.com/ for our selection of machinery.

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About us

Company details

A supplier of micro-technical services in biomaterials, STATICE designs and produces innovative made-to-measure instruments, and supports their clients from the beginning of the project through to the final production line. STATICE is a manufacturing reference in the field of implants, medical instruments, and laboratory equipment. The medical instruments and other designs developed by STATICE are used in all industries where precision is of the utmost importance:
  • Cardio-vascular
  • Neurology
  • Urology
  • Orthopaedics
  • Oncology
  • Ophthalmology
  • Instruments with minimal invasiveness etc...
STATICE was founded in 1978 by a group of engineers from the watch-making industry; at the time, they specialised in the production of made-to-measure micro-technology. The resulting outcome was two fields of specialisation: biomaterials and applied mechatronics for the medical industry, of which medical instruments and in vitro diagnostics. The R&D department then decided to double-up with the production site following suggestions and needs for their clients.
 
The R&D department has over 30 staff, of which Doctors and Engineers, a mechanical and electronics laboratory and testing area. Statice has an output of over 100 industrial projects per year, and together with their ¹SRC certification (¹Société Privée de Recherche sous Contrat - ¹A Private Company for Research Projects under Contract) granted by the BPIFRANCE/OSEO organism, and STATICE can undertake research projects over a medium and long-term range. STATICE is a regular partner in French and European industrial research projects which enables them to always be at the forefront of the most up-to-date technologies and innovations in their field of expertise; STATICE is recognised in Europe for their innovation skills.

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