With increasing societal needs the medical sector is a growth market: ageing population, development of illnesses linked to stress, the sedentary nature of work, overeating, pollution, etc., making essential the commercialisation of increasingly high performance preventive, mobility aid and patient treatment equipment.

éolane has specialised plants in France and abroad, specifically for the high mix low volume business.

With over 30 years experience behind them, éolane offers design, industrialization, production and long term TLS (Through Life Support) services for medical devices.

PROJECT

• Management of quality project (Risk analysis, Development plan, Dependability, Reliability)
• Class 1 to class 3 products
• FDA Registration with DHF and DMR
• Management of functional and environmental qualification (CE, UL, FDA, CSA)
• Validation plan
• Tests
• Verification file

SPECIFICATIONS/DESIGN

• Integrated products including electronics, electrotechnics, mechanics and software
• Expertise in mechanics from design to CATIA, INVENTOR, PROENGINEER development
• Expertise in PADS and CADENCE electronic design
• Expertise in embedded environment software design
• Design to cost
• Eco-design RoHS, DEEE, REACH, low energy consumption

INDUSTRIALIZATION/PROTOTYPING

• New Product Introduction Process
• Search for the best sources of supply
• Specific organization (Industrial Project Management)
• Team dedicated to medical products
• Appointment of a project leader specialised in the medical field
• Manufacture of prototypes and pilot batches
• Team of engineers for test bench development

MANUFACTURE/INTEGRATION

• Worldwide logistics
• Configuration management
• Real-life conditions
• Functional testing and Endurance testing
• Flow studies and lean manufacturing

TSL/AFTER-SALES SERVICE

• Analysis of risks of obsolescence to ensure product service life
• Response on customer site within 24/48 hours
• Build up of stocks of finished and semi-finished goods
• Obsolescence management (PARTMINER)