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 (EC) announced two new medical device regulations, Medical Devices Regulation (2017/745/EU) (MDR) and In vitro Diagnostic...
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...
Industrial Design: Not Just the Pretty Package Anymore
New product development strategies applied early in the design process ensure that the end product is designed for cost-effective manufacturing.
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.
Cogmedix Electrical and Software Engineering Capabilities
The Cogmedix DFcx™ Engineering Services group is committed to supporting our customers. Our engineers become an extension of any OEM design team for any project, resulting in a high probability of time to market success.
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.
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.
Cogmedix Medical Device Development Process – How to Innovate and Maintain Compliance
Medical device product development and commercialization can be challenging, especially when technology innovation is critical to developing your product. Cogmedix’s Design Control process has four distinct phases of development to maintain compliance while fast-tracking technology innovation.
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...