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April 10th, 2024
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Ensuring Compliance: Understanding the IVDR’s Summary of Safety and Performance (SSP)

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April 3rd, 2024
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Packaging Validation

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December 21st, 2023
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Decoding the First-Ever MDCG Guidelines for Annex XVI Products!

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September 26th, 2023
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The Importance of Risk Management for Medical Device Manufacturers

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August 3rd, 2023
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What is a Clinical Evaluation Plan and Why is it Important?

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July 27th, 2023
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CE Mark for Medical Devices What You Need to Know to Stay Ahead in the Industry

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May 19th, 2023
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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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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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Recent Post

April 10th, 2024

Ensuring Compliance: Understanding the IVDR’s Summary of Safety and Performance (SSP)

Read More
April 3rd, 2024

Packaging Validation

Read More
December 21st, 2023

Decoding the First-Ever MDCG Guidelines for Annex XVI Products!

Read More

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