Core Capabilities
With over 20 years in the medical device industry, Bergman Prototyping blends technical expertise, design precision, and regulatory knowledge to create prototypes that seamlessly transition into manufacturable solutions. Through innovative problem-solving and a patient-focused approach, we’ve contributed to breakthrough medical products now in widespread use.
Product Development & R&D
Innovative solutions for complex challenges. We provide end-to-end product development to turn concepts into functional, manufacturable devices.
✅ Concept exploration & industrial design
✅ Material selection & feasibility studies
✅ Market research & technology evaluation
Regulatory & Compliance Support
Streamlining FDA and ISO approvals. With deep expertise in regulatory documentation, we ensure devices meet industry standards.
✅ Design Risk Management (DRM) & Failure Mode Analysis
✅ ISO 13485 & FDA 21 CFR Part 820 compliance
✅ Risk analysis, verification & validation testing
Medical Device Prototyping
Bridging the gap between design and production. With our rapid prototyping expertise, we accelerate development and testing cycles.
✅ Proof-of-concept models & functional prototypes
✅ In-house CNC machining & 3D printing
✅ Iterative testing & validation
Manufacturing Support & Vendor Partnerships
From prototyping to full-scale production. Our strong relationships with trusted local vendors enable fast turnaround and cost-efficient manufacturing.
✅ CNC machining, injection molding, & casting
✅ Sheet metal fabrication & welding
✅ Fixture & tooling development for production efficiency
Design for Manufacturability & Assembly
Optimizing designs for efficient production. We refine products to ensure seamless scalability, reliability, and cost-effectiveness.
✅ Tolerance analysis & process optimization
✅ Material and component selection
✅ Integration of lean manufacturing principles
Our capabilities: An overview
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Product DevelopmentSketching and concepting different designs to explore all possible solutions and trade-offs for the best path forward. ➝ Specialties: InVivo Catheter, Benchtop Capital Equipment, Concepting, Manufacturing Processes
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Best Documentation PracticesMinimizing waste and ensuring manufacturing quality through proper risk analysis and requirement specifications. ➝ Specialties: Risk analysis, Requirements & Specifications, Validation & Verification
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Enclosure DesignBringing industrial design visions to life with a focus on manufacturability and cost-effectiveness. ➝ Specialties: Design for manufacturability, Design for Human Factors, Design for Ingress Protection, Lean & Six Sigma
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Plastic DesignOptimizing plastic components for efficiency and high-quality production. ➝ Specialties: Injection Molding, Structural Foam & RIM, Thermoforming, Cast Urethane, Blow & Rotational Molding
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Sheet Metal Design & WeldingIn-house prototyping for faster results and robust manufacturing. ➝ Specialties: CNC Milling & Turning, Aluminum Extrusion & Casting
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Manufacturing Tools & FixturesCreating precision tools and fixtures to streamline production and reduce waste. ➝ Specialties: Laser & UV curing stations, Thermal & Fluid applications, Test Fixtures, Cutting Fixtures
Let’s Build the Future of Medical Innovation Together
Bergman Prototyping can help take your device from concept to prototype and beyond with our innovative solutions for complex medical device technologies.
Why Choose Bergman Prototyping?
Industry Expertise
20+ years in medical device engineering, prototyping, and manufacturing.
Regulatory Compliance
Access to trusted local vendors for quick production cycles.
Fast-Turnaround Network
Rapid iteration, testing, and precision manufacturing.