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BIOMEDICAL VIEWS

Exploring MedTech Quality & Regulatory

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EU MDR Certificates issued by Notified Body

EU MDR Certificates issued by Notified Body

ByBiomedical Views July 31, 2024 EU MDR 2017/745
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EU MDR Procedure for Custom-Made Devices

EU MDR Procedure for Custom-Made Devices

ByBiomedical Views April 28, 2024 EU MDR 2017/745
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EU MDR Instructions for use

EU MDR Instructions for use

ByBiomedical Views March 28, 2024 EU MDR 2017/745
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EU MDR Scrutiny Procedure

EU MDR Scrutiny Procedure

ByBiomedical Views February 3, 2024 EU MDR 2017/745
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EU MDR Clinical Investigation

EU MDR Clinical Investigation

ByBiomedical Views December 29, 2023 EU MDR 2017/745
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IEC 62304 Software Configuration Management & Problem Resolution

IEC 62304 Software Configuration Management & Problem Resolution

ByBiomedical Views November 30, 2023 IEC 62304
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IEC 62304 Software Maintenance Process

IEC 62304 Software Maintenance Process

ByBiomedical Views October 29, 2023 IEC 62304
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IEC 62304 Software System Testing

IEC 62304 Software System Testing

ByBiomedical Views September 23, 2023 IEC 62304
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IEC 62304 Software Unit Implementation and Integration

IEC 62304 Software Unit Implementation and Integration

ByBiomedical Views August 5, 2023 IEC 62304
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IEC 62304 Software Architectural & Detailed Design

IEC 62304 Software Architectural & Detailed Design

ByBiomedical Views July 1, 2023 IEC 62304
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IEC 62304 Software Requirements Analysis

IEC 62304 Software Requirements Analysis

ByBiomedical Views June 18, 2023 IEC 62304
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IEC 62304 Software Development Planning

IEC 62304 Software Development Planning

ByBiomedical Views May 19, 2023 IEC 62304
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