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OMD Consulting’s regulatory advisors have 30 years of domestic and international class II regulatory consulting experience, specializing in handling the most complex challenges and partnering with you on the path to submission.
Our advisors have worked with a multitude of clients, including some of the world’s largest medical device manufacturers, and will ensure you are receiving the proper guidance for all stages of product development and commercialization goals.
Trusting the right partner for your business is critical and OMD Consulting’s position in the medical device industry across multiple segments, helps drive the certainty of a successful submission.
OMD Consulting offers a unique approach to assist from early-stage design through commercialization. OMD Consulting’s multidisciplinary team of experts have a deep understanding of the medical device product life cycle, and the impact certain decisions can have on regulatory success.
Years
Of Working
Experince
Element utilizes a proprietary methodology to help streamline non-clinical testing.
With 30 years of experience on a diverse range of products
Element’s experts will provide thorough test strategies
Our regulatory and consulting team can provide a regulatory and pre-clinical testing strategies
Our experts will help you perform a comprehensive risk assessment
Our regulatory team is well-versed on the Medical Device Regulations (MDR)
The regulatory landscape can be difficult to navigate, Element offers support to manage
Our regulatory team will provide the highest quality FDA submissions.
In addition to medical device regulatory guidance, we provide testing and certification services for a wide variety of medical devices and products.
Some of our testing services include:
-Wear Testing
-Orthopedic and Spine Device Testing
-Microbiological Testing
-Accelerated Shelf Life Testing
-Medical Device Battery Testing
-Medical Device Package Testing
-Medical Device Wireless/Radio Testing
-Porous Coating Evaluation
-Implantable, Diagnostic and Therapeutic Equipment Testing
Our medical device experts evaluate the environmental impact on the identification markings and function of reusable medical instruments after repeated autoclave sterilization cycles. Bringing innovative ...
OMD Consulting performs electromagnetic compatibility (EMC) and electromagnetic interference (EMI) testing for a variety of medical devices and components, including implantable devices, diagnostic tools and ...
OMD Consulting offers a comprehensive suite of testing for orthopedic devices including hip, knee, spinal and dental implants. In addition to full-service mechanical testing, our ...
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