Medical Device Consulting Services Available In Latin America
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by Emergo by ULbased in 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 ...
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by Emergo by ULbased in 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 ...
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by Emergo by ULbased in 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 ...
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Manufactured by BMP Medicalbased in 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 ...
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Manufactured by Noxilizer, Incbased in 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 ...
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Manufactured by Werth Systems GmbHbased in 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 ...
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