Product Design & Development Solutions

Designing and developing medical devices is a complex process that requires a blend of engineering, creativity, and regulatory knowledge. It is very crucial to Identify the needs of the end-users and translate them into actionable design inputs. This involves understanding the clinical environment, user workflows, and safety requirements. Based on the user requirements, we Develop multiple design concepts and evaluate their feasibility, risks, and market impact.
Product Design

  • Concept Exploration & Refinement
  • User Research and Requirements
  • Design Inputs Collection & Feasibility
  • Risk Analysis
  • Prototyping
  • Design for Manufacturability
  • Mold Design
  • Tool Manufacturing
  • Trials & Testing
  • Verification and Validation

Design History File Remediation

Regulatory Compliances