Significant and Nonsignificant Risk Medical Devices (Original Publisher)
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Unlock a deep understanding of the FDA’s risk classification of medical devices with Significant and Nonsignificant Risk Medical Devices. Published by Springer in 2024, this essential medical ebook is your go-to guide for navigating device classification, regulatory frameworks, and clinical investigation requirements—perfect for regulatory professionals, clinical researchers, and med-tech innovators.
Description
Significant and Nonsignificant Risk Medical Devices (1st Edition, 2024) delivers an authoritative and up-to-date overview of the crucial regulatory distinctions between significant risk (SR) and nonsignificant risk (NSR) medical devices. With increasing scrutiny on medical device safety and compliance, this book is a must-have resource for professionals involved in regulatory affairs, clinical research, medical product development, and healthcare compliance.
Whether you’re submitting an IDE, preparing for an IRB review, or planning a clinical investigation, this guide provides the clarity and structure needed to streamline your path to approval. It’s especially valuable for regulatory consultants, device manufacturers, biomedical engineers, clinical trial sponsors, and academic researchers.
Key Features and Highlights:
- Provides a clear explanation of the FDA’s criteria for SR vs. NSR classification
- Outlines the legal, ethical, and procedural implications for clinical trials involving medical devices
- Offers expert guidance on IDE submissions and IRB evaluations
- Discusses real-world case studies and decision-making frameworks
- Bridges regulatory theory with practical application in device development
Topics Covered:
Includes core chapters on:
- Regulatory frameworks for medical device classification
- Investigational Device Exemptions (IDE)
- Institutional Review Board (IRB) requirements
- Risk assessment methodologies
- Case analysis of SR and NSR determinations
- Compliance challenges in clinical investigations
About the Author:
The author is a recognized expert in medical device regulation, with a strong background in biomedical research, FDA compliance, and clinical trial governance. Their work is widely respected in the regulatory community and regularly cited in professional and academic circles.
File Details:
- Format: PDF
- File Size: Approx. 5–8 MB (varies by format)
- Language: English
- Compatibility: Works on Kindle, iOS, Android, PC, and Mac (via any EPUB or PDF reader)
FAQs:
Q1: Is this book suitable for someone new to medical device regulation?
A: Absolutely. While it includes advanced content, the book is written in a structured and accessible manner, making it suitable for both beginners and seasoned professionals in the regulatory space.
Q2: Does the book cover the IDE submission process in detail?
A: Yes, it provides comprehensive insights into the Investigational Device Exemption process, including how SR/NSR classification impacts submission requirements and trial design.
Additional information
| Publisher |
Springer |
|---|---|
| Published Year |
2024 |
| Language |
English |
| ISBN |
978-3031528378, 9783031528385 |
| File Size |
14.4 MB |
| Edition |
1 |
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