Your Partner in MedTech: From Simple to Complex

Engineering solutions tailored to deliver both subject matter expertise and bandwidth to tackle any project

SERVICE OFFERINGS

We know MedTech,
because we are MedTech.

40+ Years of Combined MedTech Experience

At G8Way, we seamlessly integrate into your team, offering
proven capabilities and expertise that exceed your expectations. With a focus on trust, quality, and scalability, we deliver high-value solutions tailored to the unique needs of the MedTech industry.

40+ Years of Combined MedTech Experience

We know MedTech,
because we are MedTech.

Core

Competencies

Integrity. Quality. Accountability. Performance. Excellence.

Electrical Engineering

  • Analog & digital circuit design
       -PCBA/FPGA/Flexible Circuits
  • Autoclavable electronics
  • IEC 60601/61010 compliance including EMC/EMI
  • Simulations & Stack-up analysis
  • PCBA manufacturing process
  • Failure mode assessment
  • DFX
  • Advanced circuits test development and execution
  • Component and supply chain management/PLCM

Software Engineering

  • Embedded and System Design
  • C/C++, Python, SAS, etc.
  • Bare metal or RTOS
  • memory management, static/dynamic analysis
  • User-Centered Design
  • GUI & System Development
  • Human Factors & Internationalization
  • IEC 62304 Compliance
  • SDLC from Plan to V&V
  • Safety & Risk Management
  • Cybersecurity

Mechanical Engineering

  • Design from concept through V&V to design transfer
  • 3D CAD modeling
  • Iterative prototyping
  • Mechanical test design and data analysis
  • GD&T and tolerance stack-up
  • Material science – manufacturing biocompatibility
  • DFM & CM collaboration
  • DHF assembly & maintenance
  • Packaging

Manufacturing Engineering

  • SOP/Work Instruction Development
  • Equipment & Process Verification & Validation
  • NPI/Tech Transfer
  • Supply Chain Management
  • Cost Reductions & Operational Optimization
  • Lean & Six Sigma Manufacturing
  • PPQ/PPAP

Quality Engineering

  • Failure Analysis
  • Post Market Surveillance
  • Complaints Investigation
  • CAPA Management
  • ISO 13485 / FDA / EU-MDR
  • Risk Management Creation & Remediation
  • Supplier Quality/Continuity

Core

Values

Integrity. Quality. Accountability. Performance. Excellence.

Trust

We prioritize building and maintaining trust with clients through transparent communication, seamless integration, reliability, and consistency in delivering results.

Quality

We emphasize the importance of delivering high-quality solutions and services that meet or exceed industry standards and client expectations.

Collaboration

The focus on collaboration stresses the value of working closely with clients to understand their needs, goals, and challenges. We value open communication, active listening, and mutual respect in fostering productive collaborations that drive success.

"The extensive experience and expertise that G8Way has in the MedTech field has significantly boosted project efficiency and improved quality."

–Sr. R&D Manager, Surgical Consoles OEM

"We were facing several lingering projects with deadlines approaching but lacked bandwidth to support. We partnered with G8WAY, they delivered on time quality results enabling our team to focus on core strategic projects."

-Engineering Manager, Spine OEM

“Our organization needed a trusted partner with both high level expertise and strong understanding of FDA standards to support our early-stage development. G8WAY built a cross functional team that provided both which helped us save time and money in our development.”

-Director, Sterile Disposable Startup

Connect with us.

We're ready to help you find the solutions you need. Need more info on how we can help? Drop us a line to get started.