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Third edition of ISO 14971  
This Article is about the third edition of ISO 14971 and what exactly changed.  
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Creating standard operating procedures for QM  
In a standard operating procedure (SOP), companies define their processes, for example how they develop medical devices or provide services.  
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Class 1 Medical Devices according to MDR  
Class 1 Medical Devices accoding to MDR The Medical Device Coordination Group (MDCG) has drafted a Guidance Document that describes how manufacturers should place their class 1 medical devices on t  
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Anonymization and Pseudonymization  
In a standard operating procedure (SOP), companies define their processes, for example how they develop medical devices or provide services.  
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3D Printing in Medicine: Avoiding Regulatory Traps  
3D Printing in Medicine: Avoiding Regulatory Traps If you believe Gartner's analysis, 3D printing in medicine has surpassed the “peak of unrealistic expectations”. A lot of companies are still tryi  
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MDR - Distributor Requirements  
MDR - Distributor Requirements (that also affect the manufacturers) Tuesday, October 15, 2019 The medical device regulations have significantly increased the requirements for distributors. You ne  
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CVSS  
CVSS – Common Vulnerability Scoring System In IT security the Common Vulnerability Scoring System (CVSS) is not only used to classify the degree of severity of software vulnerab  
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Medical grade software  
Medical grade software Tuesday 10 December 2019 ‘We develop medical grade software,’ claim manufacturers and development service providers, without specifying what exactly they mean by ‘medi  
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Generic device group versus device category  
Generic device group versus device category The MDR and IVDR use the terms generic device groups and device category without fully defining them. For manufacturers and notified bodies, it is impo  
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Health Care Facilities  
Effects of the MDR and IVDR on health institutions such as clinics and other operators. 14 January 2020 The MDR and IVDR contain hundreds of requirements for the manufacturers of medical devices.  
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