Regulatory Affairs for Biomaterials and Medical Devices-1E

Regulatory Affairs for Biomaterials and Medical Devices - 1E is a comprehensive guide designed to navigate the complex regulatory landscape surrounding biomaterials and medical devices. This first edition covers the regulatory requirements and processes needed to bring biomaterials and medical devices to market, with a focus on key global regulations, including those from the FDA, EMA, and other international regulatory bodies. The book provides a clear understanding of the regulatory pathways, clinical trials, risk management, and compliance standards. It also explores the key stages of product development, from concept to commercialization, offering practical advice on navigating regulatory challenges and ensuring safety and efficacy. Written by experts in the field, this text is an essential resource for professionals working in regulatory affairs, quality assurance, product development, and compliance within the medical device and biomaterials industries.

Top 5 Key Features:

1. Comprehensive coverage of global regulatory requirements for biomaterials and medical devices.
2. Focus on key regulations, including FDA, EMA, and other international bodies.
3. Guidance on clinical trials, risk management, and compliance standards.
4. Practical advice for navigating regulatory challenges in product development.
5. Essential for professionals in regulatory affairs, product development, and compliance within the biomaterials and medical device industries.

Book Information:

• Edition: 1st
• Publisher: Elsevier
• Binding Type: Hardcover
• ISBN: 9780857095428