This webinar will provide valuable assistance and guidance to all regulated companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC.
Description:
Originally created July 12, 1993 and mandatory since June 14, 1998, the Directive requires that companies wishing to sell medical devices within the EU must meet the requirements under the directive. The regulations under this mandate can vary from member country to member country concerning translation of key documents to other regulatory laws specific to that region. These additions supplement the set of harmonized standards put in place by the European Commission. These harmonized standards serve to free the flow of goods from one market to another within the EU Medical Device industry. Today, all medical devices sold in the EU must have the CE marking affixed to demonstrate compliance to this directive. If your device falls within the scope of the Medical Devices Directive, then you must meet the essential requirements of that law.
Areas Covered in the seminar :

• Identify the steps required to obtain CE Mark…and meeting compliance expectations.
• Understand how to apply and use the Conformity Assessment Procedure.
• How to classify your medical device correctly?
• Learn how to use the Technical File correctly.
• How to apply the Declaration of Conformity and why this is critical for success?
• How ISO 13485 fits in with this process as a device company?
• Learn and understand the expectations for the Essential Requirements and the Certification Process
• How is the Authorized Representative involved and why…and the ramifications of not meeting the requirements for CE Mark and 93/42/EEC for your company.

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Handouts and archived webinar presentations from Bryant & Stratton’s recent three-part series on career-advancement are now available online at http://online.bryantstratton.edu/webinar/.

The handouts, which were originally only available to webinar participants, feature specific tips on how to get ahead in one’s career and offer actionable strategies as a complement to the webinar presentations. The webinar series, which concluded on September 16, included sessions on how to jumpstart one’s career, build a professional brand and build a resilient career. Kim Dority, a seasoned career specialist and author who has been writing about and teaching courses on career development for more than a decade, led the series.