Industrial Design: Not Just the Pretty Package Anymore

Tony Wong, Industrial Design Engineering Manager Years ago, the industrial designer’s impact was not a well-recognized element of the overall...

Time to Market – Rapid Prototyping

Paul Dunleavy, Senior Vice President of Engineering In my previous blog, “Cogmedix Medical Device Development Process – How to Innovate and Maintain...

Cogmedix Electrical and Software Engineering Capabilities

Chad Graham, Electrical Engineering Manager Compared to medical devices twenty years ago, today’s medical devices are smaller, smarter and far more...

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...

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...

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,...

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...
Time to Market – Rapid Prototyping

Time to Market – Rapid Prototyping

Cogmedix has the expertise and capabilities to assist our customers at any phase of the product development process with exceptional quality, compliance and customer experience.

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Optical System Modeling

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

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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For Medical Devices, Class Really is Everything

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 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

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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