PD ISO/TR 12417-2:2022 Cardiovascular Implants and Extracorporeal Systems

Vascular Device-Drug Combination Products Local Regulatory Information

Introducing the PD ISO/TR 12417-2:2022, a comprehensive standard that provides essential regulatory information for cardiovascular implants and extracorporeal systems, specifically focusing on vascular device-drug combination products. This document is an indispensable resource for professionals in the medical device and pharmaceutical industries, ensuring compliance with local regulatory requirements and promoting the safe and effective use of these advanced medical technologies.

Key Features and Benefits

• Standard Number: PD ISO/TR 12417-2:2022
• Pages: 38
• Released: 2022-07-15
• ISBN: 978 0 539 18471 6
• Status: Standard

This standard is meticulously crafted to address the unique challenges and regulatory considerations associated with vascular device-drug combination products. It provides detailed guidance on the integration of drug and device components, ensuring that these products meet stringent safety and efficacy standards.

Comprehensive Coverage

The PD ISO/TR 12417-2:2022 spans 38 pages of in-depth information, offering a thorough exploration of the regulatory landscape for vascular device-drug combination products. It covers a wide range of topics, including:

• Regulatory frameworks and requirements
• Quality management systems
• Risk management and assessment
• Clinical evaluation and testing
• Post-market surveillance and vigilance

Why Choose PD ISO/TR 12417-2:2022?

Choosing the PD ISO/TR 12417-2:2022 standard ensures that your organization is equipped with the latest regulatory information and best practices for vascular device-drug combination products. This standard is designed to help you navigate the complex regulatory environment, reduce compliance risks, and enhance the safety and performance of your products.

Who Should Use This Standard?

This standard is ideal for a wide range of professionals and organizations, including:

• Medical device manufacturers
• Pharmaceutical companies
• Regulatory affairs specialists
• Quality assurance and control professionals
• Clinical researchers and evaluators

Stay Ahead with the Latest Regulatory Information

In the rapidly evolving field of cardiovascular implants and extracorporeal systems, staying up-to-date with the latest regulatory information is crucial. The PD ISO/TR 12417-2:2022 standard provides you with the knowledge and tools you need to ensure compliance and maintain the highest standards of safety and efficacy for your vascular device-drug combination products.

Conclusion

Invest in the PD ISO/TR 12417-2:2022 standard to gain a competitive edge in the medical device and pharmaceutical industries. With its comprehensive coverage and detailed guidance, this standard is an invaluable resource for ensuring regulatory compliance and enhancing the safety and performance of your vascular device-drug combination products.

Don't miss out on this essential regulatory resource. Equip your organization with the PD ISO/TR 12417-2:2022 standard today and stay ahead in the ever-evolving field of cardiovascular implants and extracorporeal systems.

PD ISO/TR 12417-2:2022

This standard PD ISO/TR 12417-2:2022 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics