Hazardous Substance Management for Medical Devices and In-Vitro Diagnostics - Comprehensive Regulatory Support for the Supply Chain

Instructor: Wilhelm Pfleger
Product ID: 704228
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This training program will offer an interpretation of the latest ruling of Reach SVHC. It will also discuss the RoHS directive – the four substances added to the restriction list in Annex II.

Why Should You Attend:

European Union (EU) legislation such as REACH, RoHS2 and POP embraces suppliers beyond the chemical industry, for example those placing, electrical and electronic products in healthcare, industry and consumer goods on the EU market. Recent changes in EU legislation have extended the scope of products and business that must comply with defined obligations.

Businesses have a duty to verify that their products comply. Testing is not always the most suitable or cost effective approach to compliance. Further, the unknown presence of regulated chemicals can threaten a company’s branding and reputation.

This webinar will address how to use data management solutions with a combination of strategic testing to reduce costs for a company whilst supporting their regulatory obligations and securing confidence within their supply chain. The instructor will share his learning and understanding of the practical aspects of dealing with EU legislation regarding material and environmental compliance.

Learning Objectives:

  • Reach SVHC – Interpretation of latest ruling
  • RoHS directive – Four substances added to the restriction list in Annex II
  • How environmental regulations interfere with each other
  • Compliance management

Areas Covered in the Webinar:

  • RoHS compliance
  • CE-compliance
  • REACH SVHC compliance
  • POP regulation – UN Stockholm Convention
  • Restricted substances
  • Environmental regulations
  • Supply chain management

Who Will Benefit:

  • Regulatory and compliance managers
  • CE marking and CE compliance managers
  • Medical device/invitro diagnostica manufacturers
  • Medical device/invitro diagnostica distributors
  • In-vitro diagnostics
  • Component suppliers for medical device and in-vitro diagnostics industry

Instructor Profile:

Wilhelm Pfleger has been with Intertek for more than 15 years with a deep knowledge in the regulatory field on products and chemical regulations. After leading the safety and EMC laboratory he joined the health, environment and regulatory team in 2008 and is now supporting the manufacturing locations and EU-importers as senior consultant for different environmental regulations like RoHS, REACH, POP, battery, packaging, cosmetic, food contact and biocide regulation. The Intertek team is also active in the German Working Group for RoHS, REACH, WEEE lead by the Fraunhofer Institute.

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