New Medical Device Product Development

Cogmedix is passionate about bringing commercially viable medical innovations to market. Comprehensive product development and a team of committed engineers ensure cost-effective design, manufacturing, scalability, and reduced overhead for the production of new medical devices.

Work with an Experienced, FDA-Compliant Medical Device Manufacturer

Is your medical device idea ready to change the world, but you lack the facilities and appropriate engineering talent mix to bring it to life? At Cogmedix, a dedicated team of skilled Caring Associates can provide guidance from the initial design and prototyping stages all the way through validation, manufacturing, fulfillment, and aftermarket services.

Cogmedix provides medical device manufacturing for a wide variety of industries including, but not limited to:

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  Cogmedix Caring Associate cleaning optical medical device components for assembly.

  Clinical

• Diagnostic
• Aesthetic
• Assessment
• Rehabilitation
• Surgical
• Prosthetic
• Imaging
• Telehealth
• Dental

Cogmedix leverages an established Scaled Product Launch (SPL™) strategy that ensures scalable practices and accelerated time-to-market for your innovative medical equipment design, keeping quality and compliance at the forefront. The Caring Associates at Cogmedix understand the challenges that come with new product development and introduction and have developed innovative processes and solutions to enable a seamless launch experience. Cogmedix will help you tackle any obstacle, whether it be navigating the transition between functional prototyping and scalable manufacturing, protecting your intellectual property, or reducing costs with vetted supply-chain management and design for manufacturability and assembly services.

Advanced, Flexible Manufacturing Facilities

For most OEMs, manufacturing new medical equipment can cause considerable financial strain due to the costs of capital equipment, manufacturing space, facility maintenance, and hiring competent personnel. Cogmedix CGMP facilities are fully staffed and equipped to offer all the benefits of having your own manufacturing facility without the steep costs or long-term commitments.

Cogmedix provides turnkey medical device manufacturing services and product development support to a range of companies from private equity or angel-seeded start-ups to Fortune 100 OEMs. Belief in flexible manufacturing,  the assessment and accommodation of each individual customer’s needs, and a passion for medical device innovation push Cogmedix to nurture growth and success for customers of all sizes and stages of development.

All manufacturing procedures and facilities are fully compliant with 21 CFR 820 and ISO 13485 and include access to clean room environments for maximum product safety and control.

Bring Your Innovative Medical Device or Equipment Ideas to Life

Great innovation deserves great service. By bringing your medical device production to Cogmedix, you gain access to:

• An experienced staff
• A fully equipped, ISO 13485 certified and FDA-registered and compliant facility
• Engineering support
• Flexible manufacturing
• Easy inventory management
• Low overhead for infrastructure
• Established domestic and global supplier relationships

Developing a new medical device requires a flexible manufacturing service provider. You can rely on Cogmedix for responsive and collaborative turnkey manufacturing and inventory management services. All associates are functionally cross-trained for efficiency and have hands-on experience in manufacturing for the medical industry. At Cogmedix, Caring Associates are passionate about medical innovation and take pride in bringing your devices to life. Contact Cogmedix today and see how we can help you!