Medical Device Safety Services
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based in 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 ...
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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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based in 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 ...
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by STEMartbased in USA
/EC, which outline the safety and performance requirements for active medical electrical equipment, non-active medical devices, and in vitro diagnostic medical devices. In order to place a medical device on the European market, manufacturer must obtain a CE mark. ...
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based in 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 ...
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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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