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IEC 60601-1-2 (Electromagnetic Compatibility of Medical Devices): Pay Attention to the New Edition!  
IEC 60601-1-2 (Electromagnetic Compatibility of Medical Devices): Pay Attention to the New Edition! In May 2016, the German version of IEC 60601-1-2:2014 (Edition 4) was published as DIN EN 60601-1  
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The FDA's Breakthrough Devices Program  
The FDA is trying to facilitate quicker access for critically ill patients to novel medical devices through a new program for breakthrough devices. For these devices FDA offers an accelerated approval  
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Essential Requirements - General Safety and Performance Requirements  
Essential Requirements - General Safety and Performance Requirements The Medical Device Directive (MDD) defines the "essential requirements", as the requirements that every medical product has  
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Clinical evaluation of software: Three proofs of conformity  
Clinical evaluation of software: Three proofs of conformity The same legal requirements apply to the clinical evaluation of software as to the clinical evaluation of all medical devices. This means  
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Classification and registration pathways of medical devices and IVDs in the U.S.  
Classification and registration pathways of medical devices and IVDs in the U.S. Medical devices are classified based on risk and assigned to Class I (low risk) to III (high risk). This classific  
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21 CFR part 820: FDA requirements for quality management systems  
21 CFR part 820: FDA requirements for quality management systems In 21 CFR part 820, the FDA formulates the requirements for the quality management systems of medical device manufacturers, among  
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2. Amendment to IEC 60601-1 – What has A2:2019 changed compared to A1:2012?  
2. Amendment to IEC 60601-1 – What has A2:2019 changed compared to A1:2012? As planned, there is a first Committee Draft for Vote (CDV) for Amendment 2 to IEC 60601-1. This is also referred to as I  
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Self-tests and Near-patient Tests: What EU Law Says  
A summary of the regulatory requirements for self-tests and near-patient tests in EU law +hints and tips  
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Data donation for research  
Please help improve the regulatory system! 1. Summary The regulatory system in Europe needs to be improved to ensure the provision of affordable medical devices to patients. For example, approval ti  
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In-Country Representation  
Authorized Representative for EU, US, CH, UK and NZ Medical device regulations in most countries require foreign manufacturers to designate an in-country representative. Your representative acts  
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