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.
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, contact us.
Fill out the form, call, or email. Let's start the conversation today.
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
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