What Medical Device Manufacturers Need to Know About New European Commission Regulations

Paul Dunleavy, Senior Vice President of Engineering   Transition into Medical Devices Regulation (MDR)  In May 2017, the European Commission...

Tribal Knowledge: What Is It and How Can It Be Prevented?

Scott Bridges, Senior Manufacturing Quality Engineer, CogmedixDaniel Irizarry, Manufacturing Quality Engineer, Cogmedix Tribal Knowledge, Hidden...

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...

Cogmedix

Tribal Knowledge: What Is It and How Can It Be Prevented?

Tribal Knowledge: What Is It and How Can It Be Prevented?

Scott Bridges, Senior Manufacturing Quality Engineer, CogmedixDaniel Irizarry, Manufacturing Quality Engineer, Cogmedix Tribal Knowledge, Hidden Factories Tribal knowledge in manufacturing, also known as a hidden factory, is information regarding a process that is not...

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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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