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Testing Services Product List and Ranking from 4 Manufacturers, Suppliers and Companies | IPROS GMS

Testing Services Product List

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Understanding Functional Safety

Understanding Functional Safety

Functional safety that guarantees product safety! A white paper explaining the core principles and standards.

This document is a white paper that provides guidelines for business managers to understand the field of functional safety and to identify which standards apply to their industry. It explains the functional safety standards for various industrial sectors such as automotive, industrial automation, and medical devices, as well as fundamental methods and principles such as risk management and system design principles, along with analytical techniques. Additionally, it introduces the comprehensive training and human resource development programs offered by TÜV SÜD Academy. [Contents] ■ Overview of Functional Safety ■ Methods and Techniques for Functional Safety ■ Functional Safety and Risk Management Acquired at TÜV SÜD Academy *For more details, please download the PDF or feel free to contact us.

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[Information] Application of the EU AI Act to the Medical Device Industry

[Information] Application of the EU AI Act to the Medical Device Industry

A thorough explanation of the application of AI laws to medical devices! What obligations are imposed on manufacturers and users?

This document is a white paper that examines the EU AI Act, a comprehensive legal framework regarding AI, from the perspective of its application to the medical device industry. It explains important aspects such as the impact of the EU AI Act on the medical device industry, prohibited uses of AI, risk-based classification, and obligations for transparency. In addition to discussing the relationship between the EU AI Act and the European Medical Device Regulation (EU MDR) and ensuring compliance, it also introduces the concept of a regulatory sandbox. 【Contents】 ■ Introduction ■ Important aspects of the EU AI Act concerning medical devices ■ Inconsistencies between the EU AI Act and EU MDR requirements ■ Ensuring compliance with the EU AI Act and EU MDR ■ Regulatory sandbox ■ Conclusion *For more details, please download the PDF or feel free to contact us.

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[Information] Due Diligence Requirements in the European Battery Regulation

[Information] Due Diligence Requirements in the European Battery Regulation

Towards ethical and sustainable procurement of batteries! An explanation of supply chain risk management and mitigation measures.

This document is a white paper that explains the due diligence requirements under the European Battery Regulation. It introduces the background and purpose, deadlines and applicable businesses, the establishment of management systems, a roadmap for compliance with the European Battery Regulation, and our main support services. We also offer free consultations where experts provide direct answers online. [Contents] ■ Why Battery Due Diligence ■ Highlights of Due Diligence Requirements ■ What is Risk Identification and Assessment? ■ Roadmap for Compliance with the European Battery Regulation and TÜV SÜD's Main Support Services *For more details, please download the PDF or feel free to contact us.

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Early Detection of Product Weaknesses - Introduction to HALT Testing Services -

Early Detection of Product Weaknesses - Introduction to HALT Testing Services -

Early Detection of Product Weaknesses - Introduction to HALT Testing Services -

HALT (Highly Accelerated Limit Test) is a testing method that exposes products to very high levels of temperature and vibration stress in a short period of time to reveal potential weaknesses. It has a proven track record with various devices such as smartphones and communication equipment, allowing for the early identification of structural defects and substrate issues before mass production, significantly reducing troubles in the market. We verify how much the product can withstand under harsh conditions and provide comprehensive support from investigating the causes of failures to developing countermeasures. For more details, please visit this page: https://www.toray-research.co.jp/analysis-evaluation/ana_071.html

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E&L Testing (Extractables and Leachables Testing) Service

E&L Testing (Extractables and Leachables Testing) Service

Attention pharmaceutical, medical device, and packaging device manufacturers anticipating strengthened E&L regulations for domestic sales products.

Our company can conduct E&L testing using analysis equipment managed in compliance with GMP regulations. E&L testing is already essential for applications in the United States and Europe. Recently, it has begun to attract attention domestically due to the rapid growth of the non-oral pharmaceutical market. 【Features】 ■ Over 15 years of experience in E&L testing as part of the Eurofins BPT (BioPharma Product Testing) network ■ Possession of a unique spectral database (LC/MS) capable of identifying over 1,900 compounds ■ Ownership of analysis equipment managed in compliance with GMP regulations ■ Conducting tests domestically with communication available in Japanese Our company transfers over 15 years of experience and extensive know-how from overseas labs to provide suitable guideline selection that meets the needs of various customers in Japan, planning evaluation and management methods according to risk, setting testing methods, and designing long-term leachables testing. Additionally, we offer consultations on stability testing, which has over 20 years of experience, as part of our projects, providing a total solution for approval applications. For more detailed information, please refer to the "Related Links."

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[Information] Compliance with ISO 26262 standard

[Information] Compliance with ISO 26262 standard

White paper presentation! Addressing the complexity of compliance with standards for safety-related electrical/electronic (E/E) systems.

This document introduces compliance with the ISO 26262 standard. The ISO 26262 standard describes the automotive safety lifecycle, covering management, development, production, operation, service, and disposal. This white paper outlines how the automotive industry can work to minimize product liability risks and secure stable profits. [Contents] ■ Introduction ■ Overview of ISO 26262 ■ Competencies of stakeholders involved in activities ■ Establishing a functional safety culture ■ Examples of implementation ■ Conclusion *For more details, please refer to the PDF document or feel free to contact us.

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Quick access to global markets

Quick access to global markets

An overview of the compliance requirements related to electrical and electronic products in major regions and countries.

This document provides new information on the continuously changing regulatory framework, helping to understand the challenges associated with the global market and the differences in regulations by country. When selling electrical and electronic products in the global market, manufacturers, importers, retailers, or traders are required to comply with various technical requirements and regulations. In a situation where there are no unified standards or requirements, and each country has different standards, it is necessary to understand the regulations for each country you wish to enter. [Contents (excerpt)] ■ International Approval Services ■ National Certifications (GMA) ■ Application of eBooks for National Certifications ■ National Regulations ■ TÜV SÜD Group *For more details, please refer to the PDF document or feel free to contact us.

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Speak to Experts - Free Individual Consultation with Specialists -

Speak to Experts - Free Individual Consultation with Specialists -

Experts in various industries and fields answer questions about regulations and certifications directly online.

Experts will directly answer any questions or concerns related to certification, testing, and auditing online. You can make a reservation directly on our website, and consultations last from 15 to 30 minutes at no cost. Please take advantage of this service to resolve various questions that may arise before you start certification, testing, and auditing in earnest.

  • ISO certification body
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Real Time Aging Test Service

Real Time Aging Test Service

We will conduct Real Time Aging tests at our warehouse.

We will conduct the real-time aging test described in section 8.3 of ISO 11607-1 (Requirements for sterile barrier systems and packaging systems). ▼ For more details, please download the PDF document (recommended). ▼ Customers in a hurry, please contact us using the 'Contact Us' section below.

  • Contract Inspection
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