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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.100 Laboratory medicine>11.100.10 In vitro diagnostic test systems>PD ISO/TS 16766:2024 Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency
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immediate downloadReleased: 2024-11-21
PD ISO/TS 16766:2024 Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency

PD ISO/TS 16766:2024

Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency

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Standard number:PD ISO/TS 16766:2024
Pages:22
Released:2024-11-21
ISBN:978 0 539 24592 9
Status:Standard
PD ISO/TS 16766:2024 - Manufacturers’ Considerations for In Vitro Diagnostic Medical Devices in a Public Health Emergency

PD ISO/TS 16766:2024 - Manufacturers’ Considerations for In Vitro Diagnostic Medical Devices in a Public Health Emergency

In the rapidly evolving landscape of global health, the ability to respond swiftly and effectively to public health emergencies is paramount. The PD ISO/TS 16766:2024 standard is an essential resource for manufacturers of in vitro diagnostic (IVD) medical devices, providing comprehensive guidance on how to navigate the complexities of such emergencies.

Overview

This standard, officially titled Manufacturers’ Considerations for In Vitro Diagnostic Medical Devices in a Public Health Emergency, is a crucial document for any organization involved in the production of IVD devices. Released on November 21, 2024, it addresses the unique challenges faced by manufacturers during public health crises, offering strategic insights and practical recommendations to ensure that diagnostic tools are both effective and compliant with regulatory requirements.

Key Features

  • Standard Number: PD ISO/TS 16766:2024
  • Pages: 22
  • ISBN: 978 0 539 24592 9
  • Status: Standard

Why This Standard is Essential

In vitro diagnostic devices play a critical role in the detection and management of diseases, especially during public health emergencies such as pandemics. The PD ISO/TS 16766:2024 standard provides manufacturers with a framework to ensure that their products are not only safe and effective but also rapidly deployable in times of crisis. This is particularly important as the demand for reliable diagnostic tools can surge unexpectedly, requiring manufacturers to scale up production and distribution efficiently.

Comprehensive Guidance

The standard offers detailed guidance on several key areas, including:

  • Regulatory Compliance: Ensures that manufacturers meet all necessary regulatory requirements, which can vary significantly across different regions and jurisdictions.
  • Quality Assurance: Provides strategies for maintaining high-quality standards even under the pressure of increased demand and rapid production timelines.
  • Supply Chain Management: Offers insights into managing supply chains effectively to prevent disruptions and ensure the timely delivery of diagnostic devices.
  • Risk Management: Identifies potential risks associated with the production and deployment of IVD devices and provides strategies to mitigate these risks.

Adaptability and Innovation

One of the standout features of the PD ISO/TS 16766:2024 standard is its emphasis on adaptability and innovation. In the face of a public health emergency, the ability to adapt quickly to new information and changing circumstances is crucial. This standard encourages manufacturers to embrace innovative approaches to problem-solving, ensuring that they can meet the needs of healthcare providers and patients effectively.

Who Should Use This Standard?

This standard is designed for a wide range of stakeholders in the healthcare and medical device industries, including:

  • Manufacturers: Companies involved in the design, production, and distribution of in vitro diagnostic devices.
  • Regulatory Bodies: Organizations responsible for overseeing the compliance and safety of medical devices.
  • Healthcare Providers: Institutions and professionals who rely on accurate diagnostic tools to deliver effective patient care.
  • Supply Chain Managers: Professionals tasked with ensuring the smooth operation of supply chains for medical devices.

Conclusion

The PD ISO/TS 16766:2024 standard is an invaluable resource for anyone involved in the manufacture and distribution of in vitro diagnostic medical devices. By providing clear, actionable guidance on how to navigate the challenges of a public health emergency, this standard helps ensure that manufacturers can deliver high-quality, reliable diagnostic tools when they are needed most. Whether you are a manufacturer, a regulatory body, or a healthcare provider, this standard is an essential tool for ensuring the safety and effectiveness of diagnostic devices in times of crisis.

Stay prepared and informed with the PD ISO/TS 16766:2024 standard, and ensure that your organization is ready to meet the demands of any public health emergency with confidence and competence.

DESCRIPTION

PD ISO/TS 16766:2024


This standard PD ISO/TS 16766:2024 Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency is classified in these ICS categories:
  • 11.100.10 In vitro diagnostic test systems