Services
Accelerate Your MedTech Innovations
TAG3 is your trusted partner, delivering comprehensive, turnkey solutions for medical device design, development and commercialization.
Click on the icons to learn more about the journey to developing a medical device.
Idea
Whether you are a physician or individual with an idea for a new medical device, a start-up company or large corporation, we can help you navigate the process for designing, developing and manufacturing your product.
We can support you from concept to commercialization or mix and match to help you with any aspects of this process.
Design
Transform your ideas into innovative, functional medical devices using our expert team.
- Concept Generation
- Clinical Need Assessment and Definition
- Clinical System FMEA
- Product Concept Design
- IP Assessment / Development
- Preliminary Hazard Analysis
- Rapid Prototyping (including 3D printing)
- 3D Modeling
- In-house Machining
- Finite Element Analysis
- Mechanical Design
- Electrical Design
- Concept Verification Testing
- Requirements Development
- Risk Management Plan
Develop
From concept to prototype to manufacturable product, we streamline regulated and compliant development for faster, efficient solutions.
- Detailed Product Design
- Preliminary Process Development and Documentation
- Design and Process FMEA
- COGS Estimates and Review
- Component and Assembly Specifications
- Packaging and Labeling Specifications
- Design Control System
- Design Transfer Planning
- ISO 13485 Certified
- FDA Registered and Audited
- Development Plan
- Regulatory Strategy and Filings
- Supply Chain Development
- Clinical Builds
- Simulated Use Model / Testing
- Human Factor Engineering and Formative Testing
- Feasibility Studies
- Functional Testing
- Test Method Development
- Accelerated Age Testing
- Packaging Design and Development
- Design for Manufacturability
- 3D Modeling and Design
Manufacture
Scale your production with our ISO 13485 and GMP-compliant manufacturing processes.
- Catheter Development, Extrusion, Braiding, Coil Winding, Laminating & Coating
- Balloon Development
- Assembly
- Packaging
- Process Validations (IQ, OQ, and PQ)
- Design, Verification and Validation Testing
- Transfer to Manufacturing
- At TAG3 or into your Facility
- Manufacturing Process and Test Method Verifications / Validations
- Manufacturing Tooling
- Regulatory Filings
- Commercial Readiness Planning
- Commercial Production
Launch
TAG3 can support you with your product launch as your contract manufacturing partner.
Click the icons below to learn more about the journey to developing a medical device.
Idea
Whether you are a physician or individual with an idea for a new medical device, a start-up company or large corporation, we can help you navigate the process for designing, developing and manufacturing your product.
We can support you from concept to commercialization or mix and match to help you with any aspects of this process.
Design
Transform your ideas into innovative, functional medical devices using our expert team.
- Concept Generation
- Clinical Need Assessment and Definition
- Clinical System FMEA
- Product Concept Design
- IP Assessment / Development
- Preliminary Hazard Analysis
- Rapid Prototyping (including 3D printing)
- 3D Modeling
- In-house Machining
- Finite Element Analysis
- Mechanical Design
- Electrical Design
- Concept Verification Testing
- Requirements Development
- Risk Management Plan
Develop
From concept to prototype to manufacturable product, we streamline regulated and compliant development for faster, efficient solutions.
- Detailed Product Design
- Preliminary Process Development and Documentation
- Design and Process FMEA
- COGS Estimates and Review
- Component and Assembly Specifications
- Packaging and Labeling Specifications
- Design Control System
- Development Plan
- Regulatory Strategy and Filings
- Supply Chain Development
- Clinical Builds
- Simulated Use Model / Testing
- Human Factor Engineering and Formative Testing
- Feasibility Studies
- Functional Testing
- Packaging Design and Development
- Design for Manufacturability
- 3D Modeling and Design
Manufacture
Scale your production with our ISO 13485 and GMP-compliant manufacturing processes.
- Catheter Development, Extrusion, Braiding, Coil Winding, Laminating & Coating
- Balloon Development
- Assembly
- Packaging
- Process Validations (IQ, OQ, and PQ)
- Design, Verification and Validation Testing
- Transfer to Manufacturing
- At TAG3 or into your Facility
- Manufacturing Process and Test Method Verifications / Validations
- Manufacturing Tooling
- Regulatory Filings
- Commercial Readiness Planning
- Commercial Production
Launch
TAG3 can support you with your product launch as your contract manufacturing partner.
Click the icons below to learn more about the journey to developing a medical device.
Idea
Whether you are a physician or individual with an idea for a new medical device, a start-up company or large corporation, we can help you navigate the process for designing, developing and manufacturing your product.
We can support you from concept to commercialization or mix and match to help you with any aspects of this process.
Design
Transform your ideas into innovative, functional medical devices using our expert team.
- Concept Generation
- Clinical Need Assessment and Definition
- Clinical System FMEA
- Product Concept Design
- IP Assessment / Development
- Preliminary Hazard Analysis
- Rapid Prototyping (including 3D printing)
- 3D Modeling
- In-house Machining
- Finite Element Analysis
- Mechanical Design
- Electrical Design
- Concept Verification Testing
- Requirements Development
- Risk Management Plan
Develop
From concept to prototype to manufacturable product, we streamline regulated and compliant development for faster, efficient solutions.
- Detailed Product Design
- Preliminary Process Development and Documentation
- Design and Process FMEA
- COGS Estimates and Review
- Component and Assembly Specifications
- Packaging and Labeling Specifications
- Design Control System
- Development Plan
- Regulatory Strategy and Filings
- Supply Chain Development
- Clinical Builds
- Simulated Use Model / Testing
- Human Factor Engineering and Formative Testing
- Feasibility Studies
- Functional Testing
- Packaging Design and Development
- Design for Manufacturability
- 3D Modeling and Design
Manufacture
Scale your production with our ISO 13485 and GMP-compliant manufacturing processes.
- Catheter Development, Extrusion, Braiding, Coil Winding, Laminating & Coating
- Balloon Development
- Assembly
- Packaging
- Process Validations (IQ, OQ, and PQ)
- Design, Verification and Validation Testing
- Transfer to Manufacturing
- At TAG3 or into your Facility
- Manufacturing Process and Test Method Verifications / Validations
- Manufacturing Tooling
- Regulatory Filings
- Commercial Readiness Planning
- Commercial Production
Launch
TAG3 can support you with your product launch as your contract manufacturing partner.
Your Comprehensive ISO
13485 Medtech Partner
Transform your ideas into innovative, functional medical devices using our expert team.
- Concept Generation
- Clinical Need Assessment and Definition
- Clinical System FMEA
- Product Concept Design
- IP Assessment / Development
- Preliminary Hazard Analysis
- Rapid Prototyping (including 3D printing)
- 3D Modeling
- In-house Machining
- Finite Element Analysis
- Mechanical Design
- Electrical Design
- Concept Verification Testing
- Requirements Development
- Risk Management Plan
From concept to prototype to manufacturable product, we streamline regulated and compliant development for faster, efficient solutions.
- Detailed Product Design
- Preliminary Process Development and Documentation
- Design and Process FMEA
- COGS Estimates and Review
- Component and Assembly Specifications
- Packaging and Labeling Specifications
- Design Control System
- Design Transfer Planning
- ISO 13485 Certified
- FDA Registered and Audited
- Development Plan
- Regulatory Strategy and Filings
- Supply Chain Development
- Clinical Builds
- Simulated Use Model / Testing
- Human Factor Engineering and Formative Testing
- Feasibility Studies
- Functional Testing
- Test Method Development
- Accelerated Age Testing
- Packaging Design and Development
- Design for Manufacturability
- 3D Modeling and Design
Scale your production with our ISO 13485 and GMP-compliant manufacturing processes.
- Catheter Development, Extrusion, Braiding, Coil Winding, Laminating & Coating
- Balloon Development
- Assembly
- Packaging
- Process Validations (IQ, OQ, and PQ)
- Design, Verification and Validation Testing
- Transfer to Manufacturing
- At TAG3 or into your Facility
- Manufacturing Process and Test Method Verifications / Validations
- Manufacturing Tooling
- Regulatory Filings
- Commercial Readiness Planning
- Commercial Production
These services are available to support the Design Control of your project
- Program Management per Design Control Requirements
- Budget Development and Management
- Biocompatibility Testing
- Material Analysis Management
- SEM, IFR, etc
- Sterilization Adoption and Validation
- Packaging Shipping Testing
- Electronic Quality Management System (eQMS)
- Animal Lab Planning / Management
- Cadaver Lab Planning / Management
- Human Factors Testing (IEC62366)
- Regulatory Submissions (CE & FDA)
TAG3 Tools & Resources
Access the essential tools and resources you need to support your MedTech projects. From calculators to industry standards, TAG3 Engineering provides solutions to streamline your development process and ensure precision at every step.
Resources Include:
