What is Medical Device Testing? Medical device safety testing consists of a series of specific tests which are performed to certify that a product will not suffer from interference in the applicable medical environment and will prevent unacceptable risks to patients. ...
EUROLAB offers a complete suite of medical device testing and certification services to ensure that you meet the required IEC 60601 product safety requirements recognized worldwide. Our services range from product design and prototype evaluation to formal compliance testing, certification and ongoing standa...
Our performance and safety testing offerings are designed to address a variety of medical device and laboratory equipment certification needs. Regulators update their requirements frequently while the healthcare sector strives to adapt to connected and evolving technologies. ...
Medical Device TechnologyBeckes, J. (2007) Safety Testing of Medical Devices: IEC 62353 Explained. Available at emdt: http://www.emdt.co.uk/article/safety-testing-medical-devices-iec- 62353-explained [Accessed: February 12, 2014]Backes, John: "Safety Testing of Medical Devices: IEC 62353 ...
Safety testing for the Medical Device Directive Element is compliant to the medical safety standard IEC 60601-1, which is recognized by public health authorities the world over and is the harmonized standard for equipment under the Medical Device Directive. We offer impartial third party supp...
Whole Industry Chain Services|Provide full industry chain technical services, including R&D support, safety evaluation and testing, registration, clinical, quality management system, etc. Professional Technical Team| A team of experts in the fields of medical device regulations, registration, medicine, to...
General medical device testing: Medical Device Regulation 2017/745 (MDR) Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). Electrical safety testing of medical devices: EN/IEC 60601-1: Infusomats/perfusers, ergometers, ultrasound (with tested sensors), operating theater monitors, ...
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Our testing services cover every step of product development. Independent Safety Assessment (ISA) - TÜV SÜD’s team of experts can test the functional safety concept of a medical device while it is in the design stage, and after it is ...
Medical Device EMC testing IEC 60601 Medical Device Safety Testing We leverage our product qualification and EMC expertise to help ensure that your medical devices and products are in compliance with IEC 60601 standards, and ready for export to global markets. ...