Optical System Modeling

Vladimir Krylov, Opto-Mechanical Engineering Manager Cogmedix provides comprehensive product development and commercialization services with...

Challenges of Introducing Medical Devices to Market as a Startup

John Mastroianni, Principal Electrical Engineer   Toward the end of last year, a former co-worker approached me about defining the FDA quality...

The Importance of a Structured Phase Gate Process in Product Development

Tom Mofford, Project Manager, Engineering   At Columbia Tech, we understand the dynamic challenges that can come up during any new product...

Cogmedix Medical Device Development Process – How to Innovate and Maintain Compliance

Paul Dunleavy, Senior Vice President of Engineering Medical device product development and commercialization can be challenging, especially when...

Working in Manufacturing: A Journey of Perception vs Reality

Craig Thompson, Engineering Technician Supervisor I started my journey with Columbia Tech and the Coghlin Companies as part of an acquisition 10...

For Medical Devices, Class Really is Everything

By Chad Graham, Electrical Engineering Manager As with life, the medical industry is a constant balance of risk versus benefit.  In the medical...

Cogmedix Attends BIOMEDevice Boston

Tim Briggs, Vice President of Relationship Development and Program Management Peter Rizzo, Manager of Positive Client Relations at Cogmedix, and I...

Pay Me Now or Pay Me Later

Jacob Cohen, Mechanical Engineering Vladimir Krylov, Opto-Mechanical Engineering Manager Materials Selection Flammability, Biocompatibility,...

Coghlin Companies Engineer Volunteers for STEM Event

Author: Rich Strazdas, Senior Software Engineer Every March, for the last ten years, the Boy Scouts Council covering the greater Lowell area has...

The Two Most Common Medical Device Certification Mistakes (and How to Avoid Them)

By Chad Graham, Electrical Engineering Manager At the beginning of every project, be it big or small, there are always two questions that come up...

Optical System Modeling

Cogmedix provides comprehensive product development and commercialization services with extensive knowledge and expertise in the area of optical and laser-based medical devices.

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Challenges of Introducing Medical Devices to Market as a Startup

Startups developing medical devices for the US market can often be unprepared for dealing with FDA regulations and preparing for an FDA product submission. Cogmedix understands the importance of quality and compliance, and proudly works with our customers to ensure they are meeting all required standards at all stages of product development and manufacturing.

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The Importance of a Structured Phase Gate Process in Product Development

As a new product comes to life from concept to commercialization, meeting our client’s objectives is critical to our success and theirs. In order to ensure we can fulfill each client’s objectives in the dynamic product development environment, we have found that following a structured phase gate development process provides the necessary foundation and roadmap to bring a product to market at WARP SPEED.

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For Medical Devices, Class Really is Everything

By Chad Graham, Electrical Engineering Manager As with life, the medical industry is a constant balance of risk versus benefit.  In the medical device sector, a medical device’s class is used as a means of classifying how risky a device is and, by extension, what...

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Cogmedix Attends BIOMEDevice Boston

Cogmedix recently had the pleasure of attending BIOMEDevice Boston, sponsored by MD&M. It was a great opportunity to engage with many Cogmedix suppliers, customers and design partners, as well as meet new companies showcasing their varying capabilities.

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Pay Me Now or Pay Me Later

When selecting the materials that will make up a medical device, one of the most important steps is considering the FDA requirements for flammability, biocompatibility and environment compatibility.  These requirements are necessary for a marketable device, but not for a functional prototype. It is common during technology development to focus on core functionality and delay meeting some regulatory requirements until the product design stage. Once the product design commences, it is possible to experience difficulty finding materials that meet both core functional and regulatory requirements.

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Coghlin Companies Engineer Volunteers for STEM Event

For the last ten years, the Boy Scouts Council covering the greater Lowell area has sponsored a Math Science Technology Expo. Scouts choose two STEM-related badges, ranging from aviation to weather to engineering, and receive six hours of instruction and hands-on participation in those areas.

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