Medical Device Regulations Services Available In Virginia
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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 UNITED KINGDOM
) across a wide range of product types. Software as a Medical Device (SaMD) is a specialism as we have helped numerous clients classify the device (under Rule 11 of the new Medical Device Regulation) and prepare the relevant documentation to ensure compliance with the new MDR, IEC 62304 and ISO ...
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Manufactured by Karl Storz SE & Co. KGbased in GERMANY
KARL STORZ has put in place a certified quality management system in accordance with the standards DIN EN ISO 9001:2015 and DIN EN ISO 13485:2016. In addition, the system meets the requirements of the European Medical Devices Directive 93/42/EEC Annex II and additional national regulations and legal requirements, such as the Canadian ...
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based in UNITED KINGDOM
The new Medical Device Regulation (MDR) comes into force on the 26th May 2021 replacing the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). The MDR applies to all manufacturers selling 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 S3 Connected Healthbased in IRELAND
as a medical device (SaMD) for regulated solutions, and on to launch and operation of solutions, even acting as legal ...
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Manufactured by RUA Life Sciences Plcbased in UNITED KINGDOM
Our experts offer a consultancy service, which supports your preparation of medical device files and regulatory proposals. The team is world renowned for this work and have global experience of regulatory ...
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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 GEOMED Medizin-Technik GmbH & Co. KGbased in GERMANY
the requirements of the European Medical Devices Directive 93/42/EEC Annex II on medical devices as well as other national and legal guidelines and standards, such as QSR of the US FDA. In doing so, we want to ensure that the manufactured products meet a level that our customers around the world can trust. We guarantee the ...
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based in GERMANY
When it comes to medical devices, quality and safety are especially vital. As a notified body, we can help you with your conformity assessment procedure and ensure that your active and non-active medical devices comply with EU Directive 93/42/EEC. Tap into the European ...
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Manufactured by EME srlbased in ITALY
All our products: Have CE brand, indicating that the product is complying with all European directives that regulate its usage; from design, manufacturing to the introduction in the market, putting into service of the product until its disposal. All medical devices respect the requirements of Medical Devices ...
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Manufactured by BYTEC Medizintechnik GmbHbased in GERMANY
We advise you fully in all matters relating to your medical device - regulatory, technical and economical - during all stages of the product life cycle. ...
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Manufactured by LRE Medicalbased in GERMANY
Always conscientious and quality-conscious: We completely meet our customers’ needs by providing them tailor-made solutions, designed and engineered to always be compliant with regulatory standards. In our fullservice approach that extends from the initial idea to the finished, validated diagnostic device produced in series, we ...
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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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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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