Our Facilities
Neural Devices Team NeuralGlider Inserter Improving insertion outcome
FDA Compliant Controlled Manufacturing

Take a look inside our facilities!

+ Diverse engineering and scientific team

+ Solid modeling and product development expertise

+ Electronics and software design capabilities

+ FDA cGMP small to mid-scale manufacturing capacity

+ ISO 13485 certified, MDSAP certified, FDA registered

+ WBE and WOSB certified by WBENC

+ 20,000 sq. ft., state-of-the-art, Pennsylvania facility 

State of the art rapid prototyping and manufacturing laboratory

State-of-the-art rapid prototyping and advanced manufacturing laboratory
Prusa i3 MK3+ 3D Printers

+ Part Evaluation and Design Optimization

+ Design and Simulation, including actuators and acoustics

+ Rapid Prototyping and Development through Design Freeze

+ Advanced Testing Including Lifetime and Transportation

+ Electromagnetic Compliance Testing

FDA Compliant controlled manufacturing

FDA Compliant Controlled Manufacturing Room
Ultrasonic welding in Actuated's FDA Compliant Controlled manufacturing room

FDA cGMP compliant manufacturing

+ Electro-mechanical device assembly

+ Ultrasonic and Micro TIG welding

+ Flexible quantities

+ Controlled environment with strict cleanliness, hygiene, and environmental requirements

Neural Devices Laboratory

Neural Devices Laboratory
Engineer working with the NeuralGlider Inserter

+ Improve insertion solutions for a wide range of implant types

+ Perform insertion testing in agar and ex vivo models prepared in wet lab

+ Analyze electrophysiology data for in vivo studies

+ Expand NeuralGlider compatibility to include couplers for different array types

+ Optimize performance of NeuralGlider through Keyence laser analysis

Advanced Testing Laboratory

Engineers working in the Advanced Testing Laboratory _BabyGentlestick Heel Stick Helper
Designing and testing

+ Keyence Optical and Laser System

+ FDA-required transportation testing

+ FDA-required temperature testing

+ Insertion dynamics testing

+ in vitro and in vivo model testing

Electronics and Design Laboratory 

Engineer working with Oscilloscope
Engineers working in the electronics and design laboratory

+ Printed circuit board design and testing

+ Electronic system design and testing

+ PC based control applications

+ Embedded firmware applications for electronics controls

+ Electronic designs for actuating piezo electric transducers

+ Electromagnetic Compliance Testing

Machine Shop 

CNC Lathe
Atrump Maximill

+ Speedy, efficient turnaround times

+ Close communication with engineers to implement any design changes 

+ Maintain manageable inventory levels

+ Quality Assurance Machining 

+ No minimum quantity required for orders

+ Production of custom fixtures for testing and manufacturing equipment

Usability/human factors laboratory

The TubeClear System Usability Testing
BabyGentleStick Usability Testing

+ Ensures devices are safe and effective for the intended users, uses and use environments

+ Maximizes ease of use, efficiency, and user satisfaction

+ Eliminates use errors that result in unsafe or ineffective use

+ Evaluates all points of interaction between the product and the user such as displays, controls, packaging, labels, and instructions

+ Validates outputs from human factors and usability engineering processes