Concept to Prototype Design

 

Get your project off the ground with MET's concept-to-prototype design service, supported by our team's broad experience in a wide variety of medical device design projects and sophisticated models for simulating product use, including of course CAD and FEA computer systems. At the next stage, our bench testing services focus on the assessment of products against the relevant regulatory standards or your own tailor-made testing regime. Biocompatibility testing according to ISO 10993 is key to CE marking and FDA submissions. MET's scientific team has in-depth knowledge of regulatory requirements and will advise you on all testing necessary to ensure device safety and compliance. Safety testing is conducted by specialist partners under rigorous laboratory control.



MET supports and fully documents all stages of your medical device product development project. Use our comprehensive service or choose specific support in one or two areas.

 

Design Input

  • Brain storming / concept generation
  • Access to medical experts
  • Standards review
  • Product research
  • Finite Element modelling
  • Risk Analysis / Failure Modes and Effects Analysis

Design Process

  • Project Management
  • Drafting 2D / 3D
  • Design iterations / focus groups
  • Design for manufacture
  • Material selection and analysis
  • Physical modelling / bench testing

Design Outputs

  • Master file
  • Technical file
  • FDA submission
  • Effective and profitable product

Design Implementation

  • Component sourcing
  • Product assembly
  • Packaging
  • Sterilisation

 Medical Device Development PDF