Medical Device Regulations Services In USA
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based in USA
The Food and Drug Administration (FDA) regulates all medical devices in the United States to make sure they are safe and effective. These regulations are a critical part of the medical device development process, and they will likely influence the design and testing of new ...
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Manufactured by Chemical Inspection & Regulation Service Limited (CIRS)based in CHINA
Medical Devices and In Vitro Diagnostics Product Regulatory Compliance in China. Pre-market Investigation & Analysis. Medical Devices Registration & Approval. Clinical Trial Consulting. Manufacturing and Distributing License Approval. Quality Assurance & Compliance. Risk Assessment & Management. Customs Clearance. ...
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Manufactured by SHL Medical AGbased in SWITZERLAND
SHL implements quality management systems throughout all phases of development and production to ensure consistency in all products. SHL’s quality system complies with FDA Quality System Regulation, Medical Device Regulation, and ISO 13485:2016. The system is regularly audited by customers and monitored internally through ...
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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 ...
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based in USA
At in2being, we specialize in helping both businesses and individuals navigate medical device development and design within the regulatory landscape in the most efficient way possible. in2being’s skilled med-tech professionals are the catalyst that brings customer ideas to life while achieving clearance through the FDA medical ...
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based in USA
Careful attention to product compliance and certification are an integral part of the process of developing and marketing medical devices. Certifiers, regulators,and standards-writing bodies such as Underwriters Laboratories (UL), the Canadian Standards Authority, the IEC and the FDA have been working hard to keep up with the pace of ...
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Manufactured by DIERS International GmbHbased in GERMANY
Our competent team of engineers, sport scientists and computer scientists is available for your questions and suggestions. To ensure the quality and precision of your DIERS measuring system, we offer you regular maintance services (according to Medical Device ...
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Manufactured by Busse Hospital Disposablesbased in USA
Medical Device Contract Assembly and Packaging Services; Your medical device assembly, kitting and packaging projects are in our team’s expert hands. Busse offers validated systems for all assembly and packaging tasks so that your project can be completed on time, every time. Learn more about our worry-free ...
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Manufactured by Nanosonics, Inc.based in AUSTRALIA
Earle H. Spaulding recognised a disinfection framework was required since all reusable medical devices cannot be sterilized. The Spaulding Classification met a key unmet need that today still forms the basis of international medical device disinfection ...
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Manufactured by Genesis Medical Plasticsbased in USA
In addition to machining and injection molding specific components, Genesis can assist medical device manufacturers with assembly, laser marking, industry-compliant packaging and other services for a more efficient supply ...
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based in USA
BSI Compliance Navigator is the smart, simple way to manage your regulatory information for Medical Device and In Vitro Diagnostic products with EU, UK and US requirements – helping you to get to market faster and maximize your ...
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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 ...
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Manufactured by Innovative Health LLCbased in USA
Reprocessing means collecting used single-use medical devices, shipping them to a regulated reprocessor, and buying them back at about half the price of a new device, to reduce supply costs without adding risk. After a procedure, single-use devices are wiped down and sometimes flushed, then collected from the ...
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by STEMartbased in USA
CE marking is the manufacturer's declaration that their product complies technically and administratively with the essential regulatory requirements of Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and In Vitro Diagnostics ...
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based in USA
All medical devices in the United States are regulated by the Food & Drug Administration (FDA), and understanding the FDA’s definition of a medical device as well as how the agency classifies medical devices is a crucial part of learning how to bring your ...
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based in USA
Medical devices are powerful and essential tools in the healthcare industry. Because they come in direct contact with patients and can have an effect on them, ensuring they meet safety standards is a critical part of the development and manufacturing ...
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by HingeClinicabased in USA
HingeClinica is a world class partner for Medical Device services. We render End to End Medical device MDR compliance and Regulatory services, Clinical trial, Pharmacovigilance services to Medical Devices industry. Our Medical Device team has extensive experience ...
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