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Medical Device Safety Services
13 services found
by:Bioscientia Healthcare GmbH based inIngelheim, GERMANY
We use medical devices in our laboratories. Therefore we are subject to the Medical Devices Act and the Medical Device Operator Ordinance. Paragraph 6 of the currently valid Medical Device Operator Ordinance requires us to appoint a representative for ...
by:Protheragen-ING based inNEW YORK (USA)
The safety and effectiveness of medical devices are of paramount importance in the healthcare industry. Before these devices are approved for use, they must undergo rigorous testing to ensure that they meet the necessary safety standards. Protheragen-ING Lab specializes in providing comprehensive and reliable ...
by:TÜV Rheinland AG based inKöln, 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 ...
by:IMR Test Labs based in
Understanding a material fatigue life is critical in the markets we serve, a wide range of industries, such as Aerospace Materials and Medical Device Testing, to ensure safety and reliability as well as determine the longevity of a part or product. Fatigue testing methods help manufacturers evaluate and validate the characteristics of candidate ...
Manufactured by:ARCH Medical Solutions Corp. based inScarborough, MAINE (USA)
Amplify shares your commitment to quality and regulatory compliance. We will work alongside your team to produce exceptional results through the regulatory journey. We provide superior solutions by utilizing and maintaining strong partnerships at every step of the process. Meredith May, Director of Consulting at Empirical Technologies, advises on launching safe new medical devices to ...
Manufactured by:Daeyang Medical Co., Ltd. based inGangwon-do, SOUTH KOREA
We have secured source technology for high frequency thermal therapy that has been clinically recognized for a long time, and we are developing various treatment protocols and applying them to our products. We will continue to strive to develop safe professional medical ...
by:Sirin Software based inOrlando, FLORIDA (USA)
Our skilled engineering team excels in low-level programming for embedded systems, enabling high-performance applications on diverse hardware. We adhere to top industry standards for connectivity, reliability, and performance. Plus, we provide firmware development for multiple architectures like ARM, RISC-V, x86, and ...
Manufactured by:Elos Medtech. based inRosenheim, GERMANY
Medical devices demand the highest degree of safety, functionality and efficiency. A well planned and performed validation program is the basis for a safe and efficient product and a successful product approval. puracon can support you not only in setting up a product-based validation program, but also in organizing and performing the selected ...
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 ...
Manufactured by:Double Black Imaging based inLouisville, COLORADO (USA)
The engineers at Double Black Imaging combine years of experience with technical competency and industry expertise to develop the perfect medical imaging workstation solutions for healthcare facility partners. Providing a wide array of medical LCD monitor servicing options, the team develops recommendations based on industry best practices and insider-knowledge for PACS, Mammography/Tomo, ...
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 ...
by:TÜV SÜD America Inc. based inWakefield, MASSACHUSETTS (USA)
In the medical field, practitioners utilize a range of devices to address patient health, from diagnosis to surgery. When the patient comes into contact with a medical device or material, it should fulfill its intended function without harming the patient. Therefore, all medical devices need to undergo a thorough biological risk assessment to protect the patient from any toxic, physiological, ...
by:HingeClinica based inPrinceton, NEW JERSEY (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 in working with US FDA, EMA, PDMA, SFDA, Health Canada, DCGI and ROW, regulatory Submissions and ...