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BSI Group America Inc. Announces Specialized Regulatory Training Courses for the Healthcare Industry
Date:4/27/2011

rds, essential requirements, and labeling, and the value of post-market surveillance and vigilance.
  • Medical Devices Risk Management: ISO 14971: This course is designed to provide participants with an understanding of the impact that ISO 14971:2007 has on the decision making process at medical device manufacturing firms. This one day training course helps medical device professionals gain an understanding of how ISO 14971 can improve their business and risk management efforts. Participants will also understand how ISO 14971 applies to ISO 13485:2003.
  • Process Validation for the Medical Device Industry: A one day course designed to help manufacturers gain awareness of quality requirements regarding validation and the nature of 'special processes.' Learn the generally accepted principles of validation and introduce how-to-do methods of installation, operational and production qualification.
  • Post-Market Surveillance and Vigilance: This one day post-market surveillance on the impacts of  clinical follow-up, complaint and vigilance handling for all aspects of the quality management system. Proactive and reactive sources of information are a regulatory requirement to be incorporated in your post-market surveillance procedures and are applicable to all products.
  • Device-Drug Combinations: Practical Guidance on Borderline Issues and the Consultation Process: This one day course focuses on how to determine European legislation for borderline products and provides insight and guidance related to the distinction between medical device and medicinal products. It elaborates on the ancillary medicinal substance consultation process and highlights common problems encountered by manufacturers during this process. This course also examines devices incorporating derivatives of human blood or plasma
  • Introduction to CE Marking for the In Vitro Diagnostics Directive: This one day course has been design
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