WORLD CLASS MEDICAL DEVICE PRODUCT DEVELOPMENT AND MANUFACTURING

Medical Technology Brought to Life™

Cogmedix is focused on successfully commercializing products for a broad range of dental and medical device innovators with unsurpassed quality, commitment, competency and regulatory compliance in a collaborative and transparent culture.

 

"We worked together to launch the first iteration of an extremely complex piece of equipment, with over 650 components, from 30 suppliers, in an FDA-regulated environment. We simply would not have gotten to the market without them."
Michael J. Cataldo, Chief Executive Officer, Convergent Dental

FDA Compliant Medical Device Engineering and Manufacturing Services

Cogmedix provides comprehensive product development and commercialization services, stringently adhering to FDA and ISO 13485 requirements with the latest engineering software and tracking tools to ensure your medical device is launched on time, on budget and with unconditional compliance. Fully equipped testing labs as well as portable clean rooms are also in place to support various customer requirements. Our engineering and manufacturing teams ensure that scalability and cost effectivity are optimized from day one.

Bring your innovative medical device to life

Optical and Laser-Based Medical Device Manufacturing

Cogmedix has extensive knowledge and expertise in the area of optical and laser-based medical device assembly, test and validation. Manufacturing facilities are equipped with dedicated work-cells, clean rooms and custom laser test labs that operate in accordance with state and federal safety guidelines. Cogmedix produces thousands of optical and laser-based medical devices annually for global leading innovators in the surgical, aesthetic, dental, and ophthalmic industries with exceptional compliance, competence, and commitment.

Trust the Experts for Medical Laser Assembly

Medical Device New Product Introduction with Scaled Product Launch™

Introducing a new medical device to the market can be confusing and challenging. At Cogmedix we have developed a proprietary, stringently controlled, New Product Introduction process. Leveraging our proprietary Scaled Product Launch (SPL™) process, we commercialize innovative medical devices with compliance, quality and transparency. We leverage lean manufacturing and our global supply chain to continuously reduce cost and deliver your device to market quicker than the competition.

Commercialize Your Medical Device with Scaled Product Launch™

Medical device Product DEVELOPMENT and manufacturing SUCCESS STORIES

Myomo: My Own Motion

Upper Limb Orthosis Manufacturing

The Myomo myoelectric upper limb orthosis is a Class II medical device that facilitates functional tasks and independence in patients with limited mobility. Read the full story.

OUR MISSION AND VISION

Cogmedix is a talented team of Caring Associates passionately focused on successfully commercializing products for a broad range of dental and medical device innovators. Cogmedix delivers new products to the market with unsurpassed quality, commitment, competency and regulatory compliance in a collaborative and transparent culture. Cogmedix aligns itself with innovative medical companies that maintain similarly high standards in honesty and integrity. Cogmedix is a subsidiary of Coghlin Companies, Inc., a privately held concept-to-commercialization firm spanning four generations.