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Medical Devices Specialities
- Cardiovascular
- Polymer Engineering
- Antimicrobial
- Combination Product & Tissues
- Dental
- In Vitro Diagnostics
- Nuerology
- Orthopedices
- Plastic & Gerneral Surgery
- Gastroenterology-Urology
- Obstetrics & Gynmecology
CMDC has assisted medical device manufacturers bring their products to market since 2004. Our services have helped our clients in designing, developing and validating their devices, in managing their projects and in building their own internal expertise. With our focus exclusively on the medical device industry, we understand the regulatory challenges our clients face. Our time-tested development and validation processes anticipate and address problems inexpensively on the planning board, rather than through costly rework later in the development, test or post-deployment phases. Our business model is to use full time employees with most work done at our facilities in Colorado. This provides engineering continuity for our clients. Internally, our expertise is in value engineering, material selection and surface modification. We do collaborate with outside mechanical and industrial engineering sources and usability experts for full turn-key projects. Our clients range from start-up to Fortune 50 medical device manufacturers.
Driven by CMDC’s adherence to a vetted Quality System and backed by a competent staff whose longevity with the company is legendary, the choice is clear. CMDC will help you reach your goals and get your product out the door.
Medical devices include the modeling, the design, the manufacture and testing, and the quality of biomedical devices and systems. The medical devices segment is very broad, and includes orthopedics devices, vascular and heart devices, dental materials, and neural engineering. The field also includes knee and shoulder joint biomechanics, bone mechanics, and the materials and material science of materials used in medical devices. For example, material experts can address:
Ceramics and metals on or in orthopedic devices and dental implants.
Polymers and ultra high molecular weight polyethylene (UHMPE) used in orthopedics, catheters and other implants.
Components for vascular graphs, stents and stent coatings.
Antimicrobial and anti-infective technologies and their application to a wide range of medical devices
FDA issues related to 510k registration, adverse event reports and all matters related to FDA GMP compliance and validation.
Many CMDC consultants are prepared to give unbiased expert analysis and expert testimony for intellectual property cases or litigation related to the efficacy and use of medical devices, materials of construction, and the integration of the materials and parts into a functioning system.
Marketing & Sales
In addition to engineering services, CMDC has a seasoned team of expert sales and marketing professionals. Our team has over 60 years experience in the medical device industry and has contacts at the highest levels in the major medical companies. Once your device is up off the ground, we can help make sure it makes it to the market!
Research Management
CMDC takes pride in helping small, highly innovative device companies manage the development process just as effectively as the global giants do. It’s what we call an integrated approach.There’s a lot to think about, and at CMDC, we focus all aspects of the development process on the single goal of turning your medical advance into a successful brand.For example:
Upfront consultation and planning, including regulatory, health economics and reimbursement strategies.
End-to-end clinical trial support, from trial set-up and operations to regulatory submissions.
Rapid identification and assessment of potential risks during clinical trials.
Up-to-date intelligence on changing EU/FDA regulations.
Post-marketing surveillance and registry support.
Global safety services.
You’ll find CDMC is not only capable and reliable, but also easy to work with. We’ve dealt with it all. And we’re eager to do it for you, from 10-patient feasibility studies to 10,000-patient post-marketing trials.
Material Selection and Development
Material selection for medical device is one of the first critical steps for success of your device in the market. Due to the recent Affordable Care Act legislation, there has been great downward pressure on the medical device market. CMDC can help you select the proper materials that have the correct physical and biological properties while staying cost competitive. In many cases, CMDC will help develop a surface modification on your device so performance does not have to be dependent on the bulk properties of the materials, thus reducing cost and increasing performance.
Material Selection and Development
Material selection for medical device is one of the first critical steps for success of your device in the market. Due to the recent Affordable Care Act legislation, there has been great downward pressure on the medical device market. CMDC can help you select the proper materials that have the correct physical and biological properties while staying cost competitive. In many cases, CMDC will help develop a surface modification on your device so performance does not have to be dependent on the bulk properties of the materials, thus reducing cost and increasing performance.