“We’re like technical leaders or engineering leaders where we can come in and help companies navigate the complexities of getting products approved through the FDA, EU, and other regulatory bodies.”
–Chad Gibson, Managing Partner
CMD MedTech provides technical leadership and engineering guidance to help companies navigate the complexities of getting medical device products approved through the FDA and international regulatory bodies. While we partner with other firms for mechanical engineering and parts production, we excel at leading teams through the entire development process, ensuring compliance with regulations, guidances, and standards. As a team founded by systems engineers, we focus on implementing practical solutions that help get safe, effective products to market and keep them there.
Why Choose CMD MedTech as Your Medical Device Consultant
- Expertise in leading teams from concept to production
- Deep understanding and integration of regulatory requirements and their timing in the development process
- Experience with hundreds of different medical devices
- Ability to coordinate multiple engineering workstreams simultaneously
- Access to expert team members across various specialties
- Strong partnerships with other engineering firms for comprehensive solutions
- Experience working with both established companies and startups
PRICING FOR OUR MEDICAL DEVICE ENGINEERING SERVICES
Our medical device systems engineering services are structured to provide maximum value while maintaining efficiency throughout your project lifecycle. We offer flexible engagement models, including both time-and-materials and fixed-price options, tailored to your project’s scope and requirements. While our rates reflect our deep expertise and proven track record, our efficiency and experience often result in reduced overall project costs. Contact us to discuss your project needs and receive a customized pricing proposal.
5-Step Process for Getting Started With Medical Device Consulting
5-Step Process for Success With Medical Device Engineering
Additional Services We Offer
Verification and Validation Support
We provide expertise and resources to lead your product verification and validation activities.
Software Engineering Solutions
We offer targeted software engineering leadership capabilities while coordinating with specialized partners for comprehensive solutions.
Expert Consultation
We provide access to specialized team members for specific standards like IEC 60601-1.
Project-Specific Tactical Support.
We offer focused assistance for shorter engagements and specific project phases.
Partnership Coordination
We manage relationships with mechanical, electrical, and industrial design partners to ensure seamless project execution.
FREQUENTLY ASKED QUESTIONS
CMD MedTech can bring greater efficiency and depth of experience to your team, including the ability to leverage the knowledge base of our entire staff. With the decreasing tenure of employees and loss of long-term expertise in companies, we provide consistent, knowledgeable leadership that helps get things right the first time.
The timeline and cost vary significantly based on the device complexity and regulatory requirements. For startups especially, it’s important to understand that beyond the prototype stage, there are substantial development, testing, and documentation requirements that can require significant investment.
We focus on technical leadership and engineering management, including requirements development, safety risk management, usability engineering, and cybersecurity. We partner with other firms to pair our expertise with comprehensive design engineering solutions (e.g., electrical, mechanical, and software).
As an experienced medical device consultant, we can integrate with your teams at various levels, from providing overall technical leadership to supporting specific aspects of development. Our role is often to guide teams through the maze of regulatory requirements (e.g., standards, regulations, and guidance) while ensuring efficient development processes.