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May 19th, 2023
Maven - India 10 Comments

Unraveling the Relationship between EN ISO 14971:2019/A11:2021 and the General Safety and Performance Requirements of Regulation (EU) 2017/745 & 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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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
Maven - India 10 Comments

Correction Corrective Action and Preventive Action

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May 6th, 2022
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Evolving Role of Regulatory Affairs in Medical Device Industry

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Recent Post

October 10th, 2024

MDCG 2020-7 PMCF Plan Template: A Guide For Manufacturers And Notified Bodies

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October 3rd, 2024

Medical Devices Manufactured Utilizing Tissues Or Cells Of Animal Origin

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September 25th, 2024

Import License for Medical Devices from CDSCO

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