STED (Summary Technical Documentation)

    

Global Regulatory Affairs Consulting Agency, KGMP CORP.

STED (Summary Technical Documentation)

Partner with KGMP to ensure your products comply with the regulatory standards of your target market.

KGMP is a trusted leader in medical devices consulting, providing expert guidance to navigate market-specific requirements and ensure compliance with local and global regulations, facilitating safe export and distribution.

Medical Device STED Compliance: Essential Insights for Your Business

STED (Summary Technical Documentation) is a summarized technical document typically required for high-risk medical devices, encompassing critical information such as device safety, performance, quality control, risk management, and clinical data, ensuring compliance for market access in the EU.

As a core component of the technical documentation, STED can serve as a useful foundation for preparing regulatory submissions in other countries. However, due to varying national requirements, STED may need adjustments to meet specific regulatory standards. KGMP provides comparative insights into these regulatory requirements, helping you navigate market-specific standards.

KGMP STED (Summary Technical Documentation) Service

Device data review	STED configuration review	Device-specific additional tests	STED documentation

Key Stage of Medical Device STED

STED (Summary Technical Documentation) is a vital element in securing regulatory approval for high-risk medical devices, especially under the EU Medical Device Regulation (MDR). It provides a comprehensive summary of the device’s technical and clinical data, crucial for market access in the European Union. The STED preparation process is intricate and demands meticulous attention to detail.

At KGMP, we guide manufacturers through the documentation stages, ensuring compliance with regulatory standards. Partner with us to streamline the approval process and ensure your device’s safety, effectiveness, and market readiness.

 

Main components of STED

The key stages in preparing STED for medical devices ensure that all required information is systematically collected and submitted for evaluation. Below are the main components of STED, though this list is not exhaustive.

ㆍ      Device Description and Intended Use: This stage provides a detailed overview of the device, including its purpose, target population, and intended use. It is essential for defining the device's functionality and clinical application, serving as the basis for regulatory classification and pathway determination.

ㆍ      Design and Manufacturing Information: This stage outlines the device's design, materials, and manufacturing processes to ensure consistent production and compliance with safety and performance standards. Quality management systems, like ISO 13485, are integral to this stage.

ㆍ      Risk Management and Safety: This stage involves assessing potential risks, identifying hazards, and implementing mitigation strategies to ensure compliance with international safety standards while minimizing risks to acceptable levels.

ㆍ      Clinical Evaluation and Performance Data: Clinical evidence, such as trials or post-market data, is provided to demonstrate the device’s safety, effectiveness, and low risk, ensuring it performs as intended in clinical settings.

ㆍ      Labeling and Instructions for Use (IFU): The label must include accurate information on intended use, safety, and warnings, while the IFU must provide clear guidance for proper device operation and risk minimization.

ㆍ      Regulatory Compliance and Conformity Assessment: This stage ensures the device meets regulatory requirements, including conformity to standards like ISO 14971 and IEC 60601, and compliance with MDR or other regulations in the target market.

ㆍ      Post-market Surveillance and Vigilance: After market release, ongoing monitoring is required to ensure continued safety and performance, with data collection and evaluation helping to maintain compliance throughout the device's lifecycle.

Remember that different regulations apply in each country.

Contact us today to discover how our medical device label compliance and UDI services can benefit your business.

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