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A comprehensive and Practical Guide to Clinical Investigations of Medical Devices

This book offers an overview of the entire process of clinical research in a through and easy-to-read format. It also provides valuable insights into the fundamentals of clinical research related to AI-powered software as medical devices. 

A practical handbook for professionals in the medical device industry, this book serves as a roadmap for integrating the requirements of ISO 14155 and the Medical Device Regulation (MDR) into clinical research practices. Filled with case studies, checklists, and templates, it’s an essential resource for ensuring seamless compliance and successful market entry.

Breaking Into Medtech: Your Guide to Landing Dream Roles as a Clinical Research Associate or Medical Writer

This is an essential roadmap for ambitious professionals eager to forge a career in the competitive biotechnology industry. Whether your passion lies in overseeing critical clinical trials as a Clinical Research Associate (CRA) or communicating groundbreaking scientific discoveries as a medical writer, this book is your comprehensive guide to achieving your career aspirations.

The book demystifies the paths leading to these coveted roles, breaking down the complex industry lingo, expectations, and potential career trajectories. Readers will discover the qualifications and skills that hiring managers seek in top-tier candidates, along with insider tips on how to stand out in an ocean of applicants.

This book delves into key responsibilities, from developing study protocols and conducting regular site visits, to ensuring compliance with clinical trial regulations. You’ll learn about the crucial traits of successful CRAs, such as attention to detail, organizational skills, and a robust understanding of good clinical practices. 

You’ll also find invaluable advice on crafting compelling scientific narratives, honing technical writing skills, and staying abreast of the latest industry trends and regulatory guidelines. The book offers insights into the diverse niches of medical writing, from regulatory writing to medical journalism, emphasizing the importance of precision, clarity, and a deep understanding of scientific principles.

Additionally, the book features real-world case studies and interviews with industry professionals, providing readers with a realistic view of the day-to-day challenges and triumphs encountered in these roles. The narrative is complemented with actionable strategies for personal and professional development, helping you step confidently onto your career path in clinical research or medical writing.

 

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