Device Design

Device Design

ConceptDesign & DevelopmentVerification and ValidationRegulatoryQMSProduct Launch


After conceptualizing a new medical device, the next steps are design and development. JALEX Medical offers full service design and product development engineering for your medical device and can assist with any phase of development, from concept to production. Our design engineers specialize in the creation of 3D models and drawings that take your ideas from concept to reality. In all phases of device design, special considerations are taken for manufacturability, materials, and assembly processes that will ensure your device meets your precise design specifications and user needs. During the design process, we can also develop and assemble prototypes in our state of the art lab. Once a design is complete, we work with qualified manufacturing and testing vendors to facilitate the production of your device and ensure that it meets all testing criteria required for the device type.

Throughout this process, our engineers and quality specialists will conduct design reviews and document all activities in compliance with regulatory requirements. A complete technical file and/or design history file will be compiled and provided to you to support the regulatory requirements for your device.

Don’t need full product development? All of our design services are a la carte. We will work with you to establish your design and development needs based on your business goals and strategies. Below is a list of services to help accelerate your idea from concept to market. 

Design and Development Services

  • Program management
  • Concept Generation and Product Definition
  • 2D / 3D CAD Modeling
  • Design history file and technical file creation and compilation
  • Design for Manufacturing
  • Engineering Analysis – Finite Element Analysis (FEA)
  • Material Selection
  • Rapid Prototyping (3D Printing)
  • Metals
  • Polymers
  • Sourcing contract manufacturing and testing
  • Supply chain management
  • Process development
  • Production planning
  • Packaging design
  • Sourcing contract sterilization
  • Verification and validation protocol development and execution

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