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Clinical investigation and clinical evaluation MedicalDeviceHQ

WebThe difference lies in the definitions: a clinical investigation is a new study using a medical device in patients to demonstrate the safety and performance of that …

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A guide to software as a medical device, IEC 82304-1 and AI

WebSoftware as a medical device, SaMD, is in the scope of the health software definition and part of the lower left box in the image below. The purpose of the IEC …

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What is good clinical practice (GCP)

WebGood clinical practice is defined as. “an ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. It …

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An illustrated guide to medical device software development

WebThe illustrated guide to medical device software development and IEC 62304. The IEC 62304 standard includes requirements for managing the life cycle of …

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A guide to quality management for medical devices and ISO 13485

WebThe illustrated guide to quality management for medical devices and ISO 13485. Quality management for medical devices refers to the systems and processes put in place to …

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A guide to implementing and maintaining a medical device QMS

WebImplementing a medical device quality management system, or QMS, is a regulatory requirement for medical device manufacturers. In the medical device …

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What is new in the IEC 62366-1 AMD1:2020

WebFebruary 22, 2022. All articles, Usability engineering 62366-1. In June 2020, the IEC 62366-1 standard underwent some updates. The video below will go over the main changes …

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Creating a medical device work breakdown structure

WebThe WBS (work breakdown structure) is a hierarchical decomposition of the total scope of work to be carried out by the project team to accomplish the project …

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Performing medical device risk evaluation

WebThe risk evaluation matrix can be used to determine when risk is acceptable or not. In the example above, the risk is in the unacceptable area. Had the probability of …

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Different classifications rules for medical device software

WebWith our medical device software course selection, you can choose between Software for Medical devices and IEC 62304 and SaMD, IEC 62304 and IEC 82304-1 …

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INTRODUCTION TO THE MEDICAL DEVICE REGULATION (EU) …

WebThis online course focuses on the European regulation for medical devices, the MDR. It covers an orientation of the Medical Device Regulation according to (EU) 2017/745 as …

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An alternative approach may be used if

WebRecommendations for Developing User Instruction Manuals for Medical Devices Used in Home Health Care. This guidance was written prior to the February 27, 1997 …

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IEC 62304 standard and software safety classifications

WebAn overview of the IEC 62304 standard and software safety classifications. If you are developing medical device software, then you will be working closely with the …

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Medical Device Design Control, Risk and Project Management

WebLearn how to identify and manage product specific requirements and how this process is integrated with the design control and risk management processes. The course covers …

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How to write instructions for use for medical devices

WebWhat to consider when writing instructions for use. The instructions for use is the output of multiple processes, considerations and requirements. The seven top things …

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Online Software for Medical Devices and IEC 62304 Course

WebIt covers all aspects of the IEC 62304 standard and the relationship between the IEC 62304 and other standards such as ISO 14971, IEC 60601-1 and IEC 82304–1. The course is …

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Usability engineering and risk management for medical devices

WebISO 14971, the risk management standard, defines safety as. “freedom from unacceptable risk.”. ISO 14971:2019, 3.26. In terms of usability engineering and the IEC …

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Design control for medical devices

WebDesign control is the area of requirements from the US Quality System Regulation or QSR, that apply to the design and development of medical devices. To be …

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How to estimate risk

WebThe most common way to estimate risk. The most common way to estimate the probability of occurrence of harm or, Po, is by measuring it semi-quantitatively, so …

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Medical device software risk management and IEC 62304 …

WebWith our medical device software course selection, you can choose between Software for Medical devices and IEC 62304 and SaMD, IEC 62304 and IEC 82304-1 …

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General Safety and Performance Requirements of the MDR

WebJanuary 16, 2024. All articles, Medical device regulation. When placing a medical device or in-vitro diagnostic medical device on the EU market, it is mandatory to fulfil the General …

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