Optical and Laser Centric Medical Device Engineering and Manufacturing Services

Cogmedix provides product development, manufacturing and global fulfillment services to a wide variety of medical device innovators, with a niche in commercializing laser and optically based products. We specialize in engineering and manufacturing devices that integrate different lasers and electro-optical systems along with complex accessories and consumables that include optical components.

WORK WITH AN EXPERIENCED COMMERCIALIZATION PARTNER

Cogmedix has expertise in markets that include surgical, aesthetic, dental, diagnostic, and imaging. We have manufactured thousands of Class 2 and Class 3 finished medical devices incorporating a wide range of laser technology and all classes of lasers (IEC Class 1 through Class 4), as well as thousands of non-optical medical devices of all classes. Cogmedix has a depth of knowledge commercializing laser based medical devices including systems with semiconductor lasers, solid-state lasers (including Q-Switch) and gas lasers.

Additional services related to optical beam delivery systems:

  • Beam path assembly and test (including optical elements, beam splitters, beam combiners, and reflectors)
  • Fiber connectorization
  • Fiber integration
  • Fiber delivery alignment
  • Articulating arm alignment and integration
  • Galvanometer integration

Our team brings years of experience in not only manufacturing laser and optics centric medical devices, but also designing and testing them, always keeping quality and compliance at the forefront. We have deep knowledge and experience in areas including: electrical safety testing, pressure and leak testing, near and far field laser alignment and testing, advanced optical alignment, laser radiation characterization, optical sub-assembly testing, performance verification, functional testing, electronic system troubleshooting, and recording and logging data in a multitude of platforms. 

WORLD CLASS FACILITIES AND SAFETY PROTOCOLS

 

Cogmedix maintains clean rooms appropriate for each medical device we commercialize as well as clean rooms that can be shared for various optical assemblies. We have state of the art clean rooms, laminar flow benches, and dust/particle controlled production areas. We work with our customers to design and integrate customized workspaces to ensure their unique needs are met. In addition to compliant spaces, Cogmedix has multiple environmentally controlled laser test labs equipped to ensure safety for our associates and customers at all times while performing optical alignment, calibration and testing. We have the ability to incorporate portable laser safe test rooms when and where appropriate and are highly experienced in the critical handling of lasers and optical components. Safety, compliance, and training are managed by Cogmedix’s Laser Safety Officer, and every associate involved in the powering or testing of a laser system is properly trained on laser safety.

Cogmedix has a released laser safety procedure compliant to ANSI Z136.1-2014 and a dedicated Laser Safety Officer, who is independently certified. 

IMAGING, OPTICAL AND LASER MEDICAL DEVICE ENGINEERING

Cogmedix provides comprehensive product development and commercialization services leveraging our team of laser and optics experts. The Cogmedix Engineering Services team is comprised of industry leaders with a vast knowledge of optical engineering, electrical engineering, software engineering, and mechanical engineering. A high concentration of the products we engineer are based on a laser or imaging optical system that provides the primary function and is the most critical system component. We are able to assist you at any phase of the product development process and are fully equipped to bring your product to market with the highest levels of quality, compliance and customer satisfaction.

Cogmedix utilizes a proprietary medical device engineering process, known as Design for Compliance and eXcellence™ (DFcx™). We are able to bring our customers’ vision to life through a phase gate approach with continuous improvement and open communication built in.

We understand the complex requirements of designing laser and optically based systems, and pride ourselves on compliance to 21 CFR 820.30, ISO 13485:2016 and all other appropriate safety and compliance standards.

EXCELLENCE IN OPTICAL AND LASER ANALYSIS AND MODELING

When modeling laser beam delivery systems, it is critical to understand the impact of the laser radiation coherence on the performance requirements. Diffraction and interference effects can degrade the intensity uniformity of the spot on target which is often critical in medical applications. We can analyze these effects using physical optics modeling and have an accurate prediction of the laser radiation intensity distribution on target. Another important aspect of designing laser beam delivery systems is back focus analysis. Understanding the risks of reflected energy on optical components, we can perform a back reflection analysis to ensure that when the optical design requires surfaces that focus the back-reflected light, the location of such spots are away from susceptible surfaces.

Considering that optical elements are often times among the most expensive and longest lead components of the system, thorough optical system modeling is critical. It provides us with close approximation of real-life performance and allows us to minimize development costs and schedule impact due to optical design oversights or errors.

The design of an optical system starts with the review of product requirements from which the proposed solution is derived. This is followed by performance estimates and detailed optical system modeling using raytracing software, such as Zemax. Cogmedix has extensive experience with both imaging and laser delivery optical systems and understanding of how their modeling relates to the physical system performance.

When modeling laser beam delivery systems, it is critical to understand the impact of the laser radiation coherence on the performance requirements.
Cogmedix is dedicated to providing the highest caliber product development, manufacturing and global fulfillment services to innovators in laser and optics centric medical device markets. We are committed to a streamlined process and exceptional customer experience, ensuring you never miss a market opportunity.
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