Regulatory Excellence Bundle: Medical Devices

The Regulatory Excellence Bundle: Medical Devices will help you master medical device regulations and regulatory intelligence. This curated collection brings together three vital resources, empowering regulatory professionals worldwide.

What’s Inside?

1. Fundamentals of Medical Device Regulations: A Global Perspective
   • Includes Medical device and in vitro diagnostic chapters addressing regulatory schema in the US, Europe, and additional global regions.
   • Covers the entire medical device lifecycle, from development to postmarketing.
   • Supports regulatory professionals as they navigate global compliance requirements and stay up to date with new and emerging regulations.
2. Global Medical Device Regulatory Strategy, Second Edition
   • Learn to develop a comprehensive global regulatory strategy for all types of medical devices.
   • Explore labeling, clinical aspects, risk management, marketing, and postmarketing strategies.
   • Stay informed about international regulations and the role of cybersecurity and software.
3. Regulatory Intelligence Reimagined
   • Unlock the power of regulatory intelligence with insights from experts worldwide.
   • Understand databases, public sources of regulatory precedent, health authorities, regulations, and key metrics.
   • Discover chapters on successful health authority meetings, providing actionable intelligence, and the emerging role of artificial intelligence.

Why Choose the Bundle?

• Comprehensive Knowledge: Covering regulations, strategy, and intelligence, this bundle equips you for success.
• Cost Savings: Enjoy a bundled discount (over 20% savings) compared to purchasing these books separately.
• Career Advancement: Whether you are new to the field or a seasoned professional, this bundle enhances your expertise.

Purchasing Options

This bundle can be purchased in the following formats:

• Subscription bundle.* A three-year subscription including the digital e-book versions as well as automatic updates whenever new editions and/or chapters are released during the subscription period.
• Digital e-books. Single purchase; accessible online via RAPS Library online reader and downloadable.
• Printed books. The printed bundle includes the books listed above in printed format. Once purchased, the books will be shipped directly to you.

These books can also be purchased as part of the following bundle:

• All Access Library (12-month digital subscription)

*All subscriptions listed above (excluding the All Access Library) are for three years. They grant you access to the products in the bundle. During this period, you can read the content online or download books as PDFs for offline use. You’ll also receive automatic updates to any new editions of the books and/or chapters included in your subscription. Learn more about subscriptions.