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Medical Device Regulations Services In Usa
22 services found
by:in2being, LLC based inSaline, MICHIGAN (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 ...
by:Chemical Inspection & Regulation Service Limited (CIRS) based inHangzhou, 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. IPR Protection in ...
Manufactured by:SHL Medical AG based inZug, 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 ...
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. ...
by:in2being, LLC based inSaline, MICHIGAN (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 ...
Manufactured by:DIERS International GmbH based inSchlangenbad, 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 ...
by:HingeClinica based inPrinceton, NEW JERSEY (USA)
HingeClinica providing regulatory consulting services to Pharmaceutical, Biotechnology, and API manufacture and medical ...
by:Emergo by UL based inAustin, TEXAS (USA)
For many healthcare innovators, opportunities to grow can outpace their ability to scale. Building capabilities in-house requires time and resources that many firms don’t have in the evolving commercial and regulatory demands of the healthcare ...
Manufactured by:Exact Medical Manufacturing, Inc. based inLancaster, NEW YORK (USA)
At Exact Medical, we treat every project with the same unwavering commitment to quality. Our systematic approach to quality assurance gives Exact Medical the confidence that every step - from material sourcing, validation, production and packaging to delivery - is precise and achieves our customers’ expectations. We can say with confidence we deliver the right product every ...
by:Orthogonal based inChicago, ILLINOIS (USA)
Drastically Reduce Time to Market & Adapt to Change Faster Than Your Competitors. Orthogonal applies Agile software development methods to medical device software development, allowing us to move faster while still delivering the quality, safety and reliability your device ...
by:BSI Consulting based inHerndon, VIRGINIA (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 ...
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 ...
Manufactured by:Nanosonics, Inc. based inSydney, 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 ...
Manufactured by:Busse Hospital Disposables based inHauppauge, NEW YORK (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 medical device assembly, kitting and packaging services. Contact us for more ...
Manufactured by:Genesis Medical Plastics based inCypress, TEXAS (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 ...
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 ...
by:Product Safety Consulting, Inc. based inBensenville, ILLINOIS (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 change in ...
by:STEMart based inShirley, CALIFORNIA (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 Directive (IVDD) 98/79/EC, which outline the safety and performance ...
by:in2being, LLC based inSaline, MICHIGAN (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 ...
by:in2being, LLC based inSaline, MICHIGAN (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 ...