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Usability & IEC 62366  
… Both IEC 62366-1 and the FDA insist on these tests. And there are no exceptions because of the coronavirus more... Market Research Market research is the systematic collection and evaluation of…  
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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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The EU Regulates Medical Laboratories – Are Laboratory Developed Tests Still Allowed?  
… EU Adjustments due to the transition periods Removal of section 3 e) "Effects of the ongoing coronavirus pandemic" 2021-04-22: Section 3. e) on the effects of the ongoing coronavirus pandemic…  
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Manufacturing and Marketing Personal Protective Equipment (PPE) in Compliance with the Legislation  
… assessment procedures for protective equipment that the EU has published in response to the coronavirus pandemic. g) Categorization / classification Personal protective equipment is split into…  
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IVD Admission Strategy  
… in this field function correctly. But nobody could have predicted the pandemic and the resulting coronavirus crisis with the restrictions we are all familiar with. This also meant that the application of…  
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Digital Transformation  
… The pace of the digital transformation has increased in recent years. This is not just due to the coronavirus crisis, which led to increased remote working and made quickly analyzable data indispensable. …  
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In Vitro Diagnostic Medical Device Performance Evaluation: 8 Steps to Conformity  
… processes in the body. An IVD is used to identify, for example: Tumor markers in blood Coronavirus (SARS-CoV-2) in a smear Cancer cells in a biopsy This information is crucial for making a…  
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Regulatory Science: Europe is Flying Blind  
… a desert. The fact that legislators can do better has been demonstrated in the fight against the coronavirus pandemic: Politicians and authorities have involved science/scientists and virologists. If the…  
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Laboratory Products for “Research Use Only” (RUO) – Often a Dangerous Claim  
… an undetected viral infection can cost many lives in the early stages of an epidemic or pandemic, as the coronavirus pandemic sadly demonstrated. 4. Alternatives to “research use only” products To avoid legal…  
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Planning Sample Sizes for Clinical Studies of Medical Devices and IVDs: The 6 Questions Your Statistician Must Answer  
… interval is usually used for this. For antigen tests for the detection of the SARS-CoV-2 coronavirus, the WHO has published guidelines that specify, for example, the statistical procedure for…  
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