Customization Capabilities

E3D offers its expertise, state-of-the-art equipment and advanced production systems for customized products that meet your exact requirements.

Our team will listen carefully to your specific requests and working together with our experienced R&D team will make recommendations to create a unique product that best meets your needs. Whether changing or modifying the external auto-injector shape, customizing with your colors and logo, or adding other features, our teams have the skills and experience to ensure that your specifications are met and that you receive the best possible product.

Manufacturing process & Compliance

Our highly automated processes combine sophisticated equipment with superior facilities to ensure production of consistently high-quality products no matter quantity.
State-of-the-art tooling and multi-cavity and 2C (two-component) molds in versatile injection machines produce the parts. Assembled on our fully automated production lines, the entire process from tooling to packing, to shipping, is carried out under strict quality control. All barcoded lots are stored and dispatched using computerized logistics to provide full traceability for each product the customer receives.

Our products are manufactured in our four Class 8 clean rooms:

  • Israel (2 sites): 3,350 m2/36,000 ft2
  • Italy (2 sites): 3,850 m2/41,000 ft2

 

Quality & Regulatory

It is the Policy of E3D, to supply our customers with a package of quality dimensions most suitable to their requirements.

Our quality dimensions are:

  • Constant high-performance, defect free products
  • Excellent service and customer support
  • Engineering innovations
  • On-Time delivery
  • Competitive prices


General information
Being a subsidiary of the Elcam group, E3D utilizes the Elcam Medical state of the art Manufacturing facilities and comprehensive Quality system:

 

Compliance with Quality System Regulations
Elcam Medical manufactures in a clean room environment (class 100,000, according to Federal Standard 209E. ISO 14644 class 8). Production, warehousing, components, documentation and traceability are performed in full accordance with the FDA Quality System Regulation: Title 21 CFR 820, effective from 1997.

Compliance with ISO 13485 standard
Elcam Medical Quality Assurance and Regulatory system complies with and is certified for ISO 13485 standard.

Compliance with OHSAS 18001:2007
Elcam Medical health and safety policy is in compliance with "OHSAS 18001:2007" - Occupational health and safety management systems.

Biocompatibility Testing
All materials in use comply with biocompatibility requirements according to ISO 10993-1 and USP Class V test requirements.

For additional information please contact: elcamqa@elcam.co.il