Essential Knowledge and Response to the Revised RoHS Directive in Medical Devices and In Vitro Diagnostic Devices
S50325
★CE marking, conformity assessment procedures, content of technical documentation, China RoHS management regulations!
【Venue】 Tekuno Kawasaki, 5th Floor, Room 5 Training 【Kanagawa, Kawasaki】 【Date and Time】 March 30, 2015 (Monday) 13:30-16:30 【Instructors】 Chairman of the Tokyo Environmental Management Institute, Tetsuya Matsuura CE/EMC Technology Support Specialist, Eiichi Okada *Both will lecture this part together.
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basic information
**Lecture Summary** To comply with the RoHS Directive, it is necessary to create technical documentation based on harmonized standards. The content of the technical documentation must be verifiable by a third party, free of errors, and easy to understand. However, in actual creation, companies often need to make their own judgments, and there is no guaranteed method for the best way to write it. In this seminar, we will explain as concisely as possible the minimum requirements that must be included in the technical documentation (TD: Technical Documentation), the basic concepts leading up to it, prerequisites, and recommended content.
Price information
After March 17, the cost will be 46,440 yen (including tax and text fees) for 2 people from 1 company.
Price range
P2
Delivery Time
P2
Applications/Examples of results
【Program】 1. Essence of the RoHS Directive 1-2 Overview of CE marking required by the RoHS Directive 1-3 Overview of CE marking required by the MDD/In Vitro Directive 1-4 Declaration of conformity to China's RoHS Management Measures 2. Overview of the operation of CE marking 3. Supply chain management required by the RoHS Directive 3-1 Requirements of the harmonized standard EN50581 3-2 What is the management system for restricted substances required by China's RoHS Management Measures GB/T 31274-2014? 3-3 Key points for integrating the requirements of the RoHS Directive into ISO9001 3-4 Developments in Japan's new information transmission scheme (SHELPA) 4. What are technical documents in CE marking? 4-1 Why are technical documents necessary? 4-2 Required content for technical documents 4-3 Detailed description of appropriate content for product descriptions 4-4 Specific examples of product descriptions 4-5 Compliance methods for the RoHS Directive 4-6 Supplier evaluation (example) 4-7 Explanation of sample technical documents 4-8 How to write a declaration of conformity 4-9 Other information (FAQ collection, RAPEX, etc.) 【Q&A and Business Card Exchange】
Company information
Our company has developed its business from "seminar planning" to various forms such as "lecturer dispatch," "publishing planning," "technical consultant dispatch," "trend research," "business matching," and "business development consulting," in order to support clients in a wide range of fields including chemistry, electronics, automotive, energy, medical devices, food, and building materials. By doing so, we have advanced our company and opened up new markets. AndTech promises to continue listening to our clients' voices, entering the business areas and markets they desire, and to remain a company that is loved by our clients, as we share their challenges, think together, and forge new paths.
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