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January 13th, 2023
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Amended transition timelines of Regulations (EU) 2017/745 and (EU) 2017/746

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December 15th, 2022
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European Commission to consider extensions to MDR and IVDR deadlines?

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November 29th, 2022
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Quantification of Benefit – Risk Analysis

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November 23rd, 2022
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The routes to conformity

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October 11th, 2022
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Clinical Development Plan (CDP)

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October 3rd, 2022
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Identification and Traceability in Medical Device Industry

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August 29th, 2022
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Verification Versus Validation of Processes in Manufacturing Medical Devices

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August 22nd, 2022
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Overall Residual Risk-How to Evaluate it?

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June 16th, 2022
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Is your product a LEGACY Certified under IVDD or OLD IVD DEVICE Self-certified under IVDD? Then you have to know this!

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May 17th, 2022
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Correction Corrective Action and Preventive Action

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Recent Post

January 13th, 2023

Amended transition timelines of Regulations (EU) 2017/745 and (EU) 2017/746

Read More
December 15th, 2022

European Commission to consider extensions to MDR and IVDR deadlines?

Read More
November 29th, 2022

Quantification of Benefit – Risk Analysis

Read More

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