FDA-Compliant Medical Device Engineering and Development: Design for Compliance & Excellence (DFcx™)
Complex Electro-Mechanical Medical Devices and Laser-Based Technologies
Cogmedix differentiates itself by providing turnkey manufacturing services for complex electromechanical medical devices with a unique niche in laser and optically centric devices. Cogmedix has shipped thousands of devices to dozens of innovative medical device OEM’s, incorporating some of the most advanced electronics, sensors, user interfaces, robotics, lasers, optics, and associated beam delivery technologies. Cogmedix complements its manufacturing services with a full range of medical device design and engineering services, branded as Design for Compliance and eXcellence™, or DFcx™.
Compliance and Safety in Your Design with Proprietary DFcx™ Services from Cogmedix
The term DFx is commonly used in our industry where the x represents safety, quality, reliability, assembly, serviceability, cost, and other important factors for a particular product. Cogmedix has taken that practice one step further by extending its core company motto of Cogmedix = Compliance™ into the product development area as well. Compliance to 21 CFR 820.30, ISO 13485:2016, and the appropriate safety standards are the foundational pillars of our DFcx™ philosophy.
The Design for Compliance and eXcellence™ Process
The backbone of the DFcx™ development process is a traditional linear waterfall methodology where full product development programs are structured with a phase gate approach: Phase 0, Phase 1A, Phase 1B, and Phase 2. Phase 0 is intended to capture all market, user and product requirements in a design input document such as; Product System Specification (PSS), Software Requirement Specification (SRS) and more. We offer Design Control services to customers as well, where Phase 0 starts the Design Controls process and the beginning of the Design History File. This document is drafted, reviewed and approved by a collaborative team consisting of members from our customer and members from Cogmedix. The PSS represents our design inputs (our guiding document) which drive design outputs. A high level outline of our phase gate approach is shown below:
- Phase 0 – Design Inputs and Product Requirements captured
- Phase 1A – Design Outputs generation, build test beds and Alpha prototypes
- Phase 1B – Beta prototypes are designed and built, implementing any changes required from Phase 1A functional and verification testing (this may include EMC and product safety testing and analysis)
- Phase 2 – Finalize Device Master Record, Device History Record, Design History file, and start the transfer of our proprietary new product introduction process, Scaled Product Launch (SPL™)
DFcx™ Team and Services Offered
Cogmedix offers a wide range of services under our DFcx™ approach to product development, ranging from technical gap analysis to full medical device design from a provided set of requirements. We will happily assist you and your company as a standalone service provider or as a complementary technical resource to your in house team or your third party partners.
The Cogmedix medical device product development team is comprised of industry leaders in engineering – including optical engineering, electrical engineering, software engineering, and mechanical engineering. Each program is managed by a dedicated Program Manager ensuring that the “voice of the customer” is well represented each and every day. We round the team out with quality and manufacturing engineers to help ensure a compliant design process and smooth transition into scalable manufacturing.
Our unique approach also allows us to build talented teams with a variety of engineering resources including these provided by our sister company, Columbia Tech.
Our facilities contain flexible work spaces dedicated to our engineering group, as well as several test labs that are compliant with laser safety requirements.
Minimize Delays and Mitigate Risk – We are Truly Aligned with Your Needs
Cogmedix provides its world class design services exclusively to products that have a high likelihood of later being manufactured by Cogmedix, in accordance with ISO 13485:2016 and FDA quality system regulations. This simple, but important factor ensures we are aligned with your needs to get your innovative medical device into manufacturing and to market, always keeping speed to market, cost, manufacturability and compliance at the forefront.
Our medical product engineering service is another avenue for us to help customers reduce their time to market in a compliant manner. We streamline the process to ensure your device moves swiftly through engineering and into production without compromising quality. Together we will help ensure you don’t miss a market opportunity. Remember…we build what we design!
Contact Cogmedix today to discuss your organization's needs and aspirations. Cogmedix can help you grow, thrive and profit.