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Medical Device Consulting Services
7 services found
Manufactured by:BMP Medical based inSterling, MASSACHUSETTS (USA)
BMP Medical has the ability to consult with our customers on both the design of their parts and the design of their tooling. We partner with local vendors to provide medical device design consultation from concept to final product. Often times, we offer advice and assistance when the mold and part ...
by:Emergo by UL based inAustin, TEXAS (USA)
Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies. Depending on where you plan to sell your device(s), ...
by:Emergo by UL based inAustin, TEXAS (USA)
Medical device regulations in most countries require foreign manufacturers to appoint an in-country representative. Your representative acts as your liaison to regulatory authorities and assists with device registrations and vigilance/adverse event reporting. It’s important to choose a representative who is familiar with the regulatory requirements for your product to act in the best ...
by:Emergo by UL based inAustin, TEXAS (USA)
Regulators in most medical device markets require registrants to meet post-market surveillance (PMS) obligations to maintain compliance. However, PMS rules can vary between different medical device markets, requiring manufacturers to develop tailored rather than one-size-fits-all approaches. With deep expertise in post-market surveillance requirements, Emergo is equipped to act as your compliance ...
Manufactured by:Noxilizer, Inc based inHanover, MARYLAND (USA)
Noxilizer’s expert in-house microbiology and materials science team will work with you to perform sterilization testing to your requirements. We offer a wide range of testing services that conforms with ISO standards both in-house at our Hanover, MD facility and through external labs. Each customer has a dedicated team working through every step of the ...
by:Emergo by UL based inAustin, TEXAS (USA)
It is easy to make mistakes in the regulatory process that can delay market entry or incur unnecessary costs. With help from Emergo’s medical device RA/QA consultants, you can pursue the most efficient regulatory route to approval and registration for your device, and maintain compliance with post-market requirements ...
Manufactured by:Werth Systems GmbH based inHiddenhausen, GERMANY
The pre-installation, localized support and the physical installation to the treatment area. The law regarding health care devices and materials require in depth expertise. A standard office-PC may be installed in a medical environment without thinking further of the consequences. A computer being installed in a operating room or in a intensive care area is a very different process. Lack of ...