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State of the Art in Clinical Evaluation: A Strategic Approach to MDR Compliance
State of the Art in Clinical Evaluation: A Strategic Approach to MDR Compliance Introduction The term “State of the Art,” often abbreviated as SOTA or SoA, has gained...
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Decoding "State-of-the-Art" in EU's Medical Device Regulation: A Comprehensive Guide
Decoding “State of the Art” in EU’s Medical Device Regulation: A Comprehensive Guide Introduction The term “state-of-the-art” is a recurring theme...
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Exploring the Ambiguities of MDR: Understanding "State-of-the-Art" in Medical Device Regulation
Exploring the Ambiguities of MDR: Understanding “State-of-the-Art” in Medical Device Regulation Introduction The term “state-of-the-art” is frequently used in the context of the...
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State of the Art in MDR: Exploring the Evolving Terrain of Medical Device Requirements
State of the Art in MDR: Exploring the Evolving Terrain of Medical Device Requirements Introduction: The Medical Device Regulation (MDR) is a dynamic framework, continuously...
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Clinical Evaluation of Medical Devices: A Regulatory and Practical Paradigm
Clinical Evaluation of Medical Devices: A Regulatory and Practical Paradigm Introduction: In the meticulous pathway of medical device development, Clinical Evaluation emerges as a pivotal phase. It is...
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Delving Into the Clinical Evaluation Report: A Pivotal Step in Medical Device Validation
Delving Into the Clinical Evaluation Report: A Pivotal Step in Medical Device Validation Introduction: The journey of medical device development is laden with regulatory hurdles, aimed at ensuring the...
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Unveiling the Clinical Evaluation Process in Medical Device Development: A Regulatory Imperative
Unveiling the Clinical Evaluation Process in Medical Device Development: A Regulatory Imperative Introduction: In the stringent domain of medical device development, the Clinical Evaluation process emerges...
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Interplay of Clinical Evaluation and Clinical Investigation: A Regulatory Perspective
Interplay of Clinical Evaluation and Clinical Investigation: A Regulatory Perspective In the domain of medical device development, adherence to the Medical Device Regulation...
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Bridging the Divide: Intersecting Realms of Clinical Evaluation and Clinical Investigation
Bridging the Divide: Intersecting Realms of Clinical Evaluation and Clinical Investigation In the intricate realm of medical device development, understanding the nuances between...
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Comprehensive Guide to Clinical Evaluation of Medical Devices: Interpretation and Application of EU MDR and MDCG Guidelines
Comprehensive Guide to Clinical Evaluation of Medical Devices: Interpretation and Application of EU MDR and MDCG Guidelines Introduction The objective of this blog post is to elucidate the regulatory landscape...