MEDICAL DEVICE DEVELOPMENT

Concept Through Manufacturing

Development Services

 

5

Feasibility Analysis

5

Design and Prototyping

5

Regulatory and Manufacturing

Products That Impact Lives

Medical Device Development

Medical device development requires a special team. Design and engineering is just part of the picture. A successful medical device requires significant development documentation, regulatory work, design validation, and more prior to launch. Our medical device development and manufacturing group brings the complete package. From feasibility analysis through manufacturing – and everything in between, we’ve got you covered. 

Feasibility & Evaluation
  • Requiremenets Capture
  • Product Specification Development
  • Medical Device Patent Search
  • RFP management
Design and Engingeering
  • Conceptual Development
  • Industrial Design
  • Material Research & Spec
  • Engineering
  • Test Method Development
  • DHF Generation
  • DFM / DFA / DFx
  • Packaging Design
  • QA / QC Requirements Development
Design Verification
  • Risk Analysis / FMEA
  • Design Documentation
  • Design Verification Testing
  • Detailed Specification
Validation
  • Design Validation
  • Componenet & Supplier Validation
  • Process / Sterilization Validation
  • Regulatory Submissions
Design Transfer
  • Device Master Record
  • Production Ramp
  • Lean Production Process
  • Packaging and Labelling
  • Continuous Improvement Program Initiation

Feasibility Analysis and Design

Our medical device development projects are different. We engage our manufacturer early in the development process to make sure that all subsequent development aligns with functional needs, material constraints, and regulatory goals. 

Our proven team of world-class engineers will take the product through concepting, engineering, prototpying, test planning, and more. We work in conjunction with your team, to ensure that the product comes to life in alignment with your business needs.

Design Verification and Validation

As your project moves into the design verification stage, our engineers and manufacturing teams will work together to characterize product risk, produce the requisite design documentation, oversee testing, and update designs / specifications based on test findings. 

Design validation efforts focus on defining the complete product supply chain, qualifying componenet suppliers, validating the sterilization process if applicable, and preparing regulatory submissions. 

Design Transfer

As production begins, our team finalizes production labelling and packaging, produces the device master record, implements lean production process, and begins the continuous improvement program specific to the product. 

Beyond production startup, our engineering and manufacturing teams are here to support you through product line extensions, continuous improvement, product updates, and more. 

Recent Projects

Contact Us

 

For press releases, interviews or generic questions, please get in touch with us below. We're excited to chat with you about your next project!

 

3131 W State Street #230 Boise, Idaho 83703

(208) 391-4000

info@sgwdesignworks.com