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Specialized Regulatory Training Courses for Health Care from BSI

Seven on-site courses reflect requirements of the latest amendments to the Medical Device Directive

Published: Tuesday, May 3, 2011 - 09:47

(BSI: Reston, VA) -- BSI Group America Inc., a leading provider of total solutions for certification and standards announces the launch of its Specialized Regulatory Training with courses targeted specifically for the medical device industry. Available on site, these specialized regulatory courses reflect requirements of the latest amendments to the European Union (EU) Medical Device Directive (MDD 93/42/EEC) enabling attendees to comply efficiently with regulations in a timely manner. Courses are lead by expert trainers who understand the industry and regulatory challenges that companies face.

As a global leading notified body, BSI understands the challenges companies face when looking to broaden their employees’ knowledge and understanding of medical device regulations and standards. In fact, more than 70 percent of the top medical device manufacturers worldwide are trained by BSI. Based on a philosophy of accelerated learning processes involving dynamic group exercises and workshop sessions, BSI medical device course attendees leave with practical tools to apply to their own situations.

Holding a training course on site at a customer’s facility allows for exclusive training of company employees, and eliminates travel expenses and time out of the office. The courses are readily adaptable to meet specific client requirements.

The new courses include:

Introduction to CE Marking. This course is designed to provide a top level overview of the guidelines of the EU Medical Device Directive (MDD 93/42/EEC) and comprehensive information on the MDD 2007/47 changes.
Medical Devices CE Marking. This course discusses the EU classification of medical devices, the European CE marking approach, the quality assurance requirements for medical devices sold in Europe, and changes coming to the MDD. The course will enable you to recognize the role of standards, 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 effect 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 effects 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 designed to introduce the In Vitro Diagnostics Directive (IVDD), the types of product covered by the directive, and the regulatory framework required for placing IVD products on the European market. On completion of training, participants will be able to apply knowledge of the directive to the development of IVD products as well as their ongoing maintenance to achieve continued regulatory compliance throughout the life cycle of the product.
Application of the In Vitro Diagnostics Directive. A three-day course to explore the IVD Directive, gain a greater understanding of the requirements to enable IVD devices to be placed on the European market. Participants will be able to apply the requirements of the directive to create technical documentation to support the product throughout its life cycle. Managers and quality/regulatory professionals responsible for all aspects of IVD CE marking, as well as internal and external auditors, will benefit from attending this course.

For full course descriptions and more information on how your company can benefit from BSI’s new Specialized Regulatory Training, visit www.bsiamerica.com/regulatorytraining.


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BSI (British Standards Institution) works with more than 80,000 clients in 172 countries to help them adopt and cultivate the habits of excellence. Clients are trained and provided with practical guidance for implementation alongside a suite of compliance tools. BSI is assessed and accredited by more than 26 accreditation bodies including ANSI-ASQ National Accreditation Board (ANAB) and United Kingdom Accreditation Service (UKAS). BSI’s influence plays a key role within the International Organization for Standardization (ISO). As one of the founding members, it ensures that international standards address business and societal needs, while delivering real benefits to organizations.