What you'll learn
Understand the Clinical Evaluation Report (CER) Writing Process: Learn the essential components and steps involved
Comprehend Regulatory Requirements: Gain insights into the regulatory landscape governing CERs
Conduct Device Evaluation and Clinical Data Analysis: Acquire the skills to evaluate medical devices and analyze clinical data to support CER development
Create Compliant and Comprehensive CERs: Master the art of authoring comprehensive, compliant, and evidence-based CERs tailored to specific device types.
Requirements
No specific prerequisites are required to enroll in this course. However, a background in medicine, pharmacy, science, or a related discipline is beneficial. This course is suitable for: Professionals with a minimum of 4 years of post-secondary education in medicine, pharmacy, science, or allied disciplines. Recent graduates interested in pursuing a career in clinical research for medical devices. Experienced professionals seeking to enhance their expertise in clinical evaluation report (CER) writing for medical devices. Individuals from diverse educational backgrounds who wish to explore the field of medical device research and understand the supplementary education needed to excel in this industry.
Description
Unlock the key to creating precise and compliant Clinical Evaluation Reports (CERs) with our comprehensive Udemy course. Designed for professionals in the medical device industry, quality managers, regulatory affairs experts, and aspiring clinical evaluators, this course offers a step-by-step guide to mastering the art of Clinical Evaluation Report Writing.What You'll Learn:Fundamentals of Clinical Evaluation: Gain a solid understanding of clinical evaluation principles, regulations, and the role of clinical reports in the medical device industry.CER Structure and Components: Learn to structure your reports effectively, including device description, context of evaluation, benefit claims, risk assessment, and more.Data Collection and Assessment: Master the process of data collection, evaluation, and conclusion drawing, with in-depth insights into source evaluation and documentation.Scientific Writing: Enhance your scientific writing skills with tips for maintaining clarity and objectivity in your reports, citing sources correctly, and using the appropriate writing style.Interplay with Regulatory Requirements: Explore the connections between clinical evaluation, risk management, clinical investigation, post-market surveillance, and post-market clinical follow-up, ensuring compliance with MDR and other regulations.Join us on a journey to unlock the secrets of Clinical Evaluation Report Writing and elevate your career in the medical device field. Enroll now to embark on a path toward mastery.
Overview
Section 1: Section 1: Introduction
Lecture 1 Introduction
Section 2: Section 2: Overview of Clinical Data Collection and Evaluation
Lecture 2 Overview of Clinical Data Collection and Evaluation
Section 3: Section 3: Overview of the European regulations
Lecture 3 Overview of the European regulations
Section 4: Section 4: additional MDR requirements compared to the MDD
Lecture 4 Additional MDR requirements compared to the MDD
Section 5: Section 5: MEDDEV 2.7/1
Lecture 5 MEDDEV 2.7/1
Section 6: Section 6: Exemptions from Clinical Evaluation
Lecture 6 Exemptions from Clinical Evaluation
Section 7: Section 7: Documenting Clinical Evaluation
Lecture 7 Documenting Clinical Evaluation
Section 8: Section 8: CER content and literature search
Lecture 8 CER content and literature search
Section 9: Section 9: CER Report and Drawing Conclusions
Lecture 9 CER Report and Drawing Conclusions
Section 10: Quiz
This course is ideal for recent graduates as well as experienced professionals in the fields of science, medicine, and allied disciplines who are interested in building a career in clinical research, particularly in clinical evaluation report (CER) writing for medical devices. It is also suitable for graduates from other areas looking to understand the educational requirements necessary to enter the dynamic world of clinical research and development within the medical device industry. Whether you are starting your career or seeking to enhance your skills, this course provides valuable knowledge and insights into the critical field of CER writing for medical devices.

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