​​Engineering for Regulated & Performance-Critical Products

We support product teams in medical, mobility, and performance industries—delivering engineering execution where reliability, compliance, and speed matter.

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Companies We service

These industries have more opportunity than the companies have engineering and design capacity! 
How do you build lean without sacrificing capacity?

Medical Device Innovators (Class I & II)

​Including instruments, mobility and rehabilitation equipment, orthotics & prosthetics, and physical therapy devices.​

Wellness & Performance Equipment Innovators​

Mechanical and electromechanical systems for exercise, strength, and rehabilitation. 

If your company is in this industry and ready to build, hassle free

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medical device Innovators (class i & II)

Engineering support for regulated products requiring quality management system, good manufacturing processes, documentation, and compliance.

​What We Understand:

• FDA-regulated development and design controls
• Verification & validation requirements
• Risk analysis and traceability
• User needs and coding and billing
• Transition from prototype to production 

Where We Help:

• Developing requirements, concepting solutions, and developing prototypes
• Advancing early-stage concepts into structured development
• Supporting internal teams during peak workload
• Executing engineering and documentation

Example Applications:

• Instruments and electro-mechanical systems
• Hand-held devices for airway or examinations
• Mobility and rehabilitation equipment
• Orthotics, prosthetics, and assistive technologies
• Physical therapy systems​

​Wellness & Performance Equipment Innovators

Engineering for strength, durability, and high-performance use.

What We Understand:

• Structural integrity and load conditions
• Repetitive use and fatigue
• User safety and ergonomics
• Scalable manufacturing

Where We Help:

• Research and development
• New product development
• Product improvements and redesigns
• Structural validation and testing
• Design for manufacturing and cost reduction.

Example Applications:

• Strength training equipment
• Rehabilitation exercise systems
• Consumer and commercial fitness products

ENGINEERING CAPABILITIES ACROSS INDUSTRIES

• Mechanical design & system integration - CAD design of assemblies, tolerance stack-ups, and multibody dynamic analysis
• Prototyping and iterative development - Capabilities to build and test electromechanical systems
• Verification & validation - Standard process based on ISO good manufacturing processes requirements
• Failure analysis and problem solving - FEA and Design Failure Modes Effects Analysis

hOW WE ENGAGE

• Embedded engineering support
• SME consultation
• Project Based R&D - QLS team for specific project
• Retainer-based capacity

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