More than 70% of the top 100 Medical Device companies chose BSI as an expert training provider.
BSI is one of the world’s leading providers of training, conferences, information and knowledge on standards, regulatory approval and business improvement for local and global audiences. Our years of experience gained through being a worldwide leading Notified Body has helped us to understand the challenges that companies are faced with when looking to broaden their employees’ knowledge and understanding of medical device regulations and standards. We have expert trainers who will strengthen your learning experience across the full portfolio of medical devices.
At BSI, we understand the importance of small interactive group sessions that strengthen the learning process and our course structure has been developed through listening to customer needs to ensure they receive the best learning experience.
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Introduction to CE Marking
1 Day
This course is designed to provide a top level overview of the guidelines of the European Medical Device Directives MDD 93/42/EEC and comprehensive information on the MDD 2007/47 changes. Read More
Medical Devices CE Marking
3 Days
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 coming changes 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. Read More
Medical Devices Risk Management: ISO 14971
1 Day
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. Read More
Post-Market Surveillance and Vigilance
1 Day
This one day post-market surveillance including clinical follow-up and complaint and vigilance handling impacts on 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. Read More
Device-Drug Combinations: Practical Guidance on Borderline Issues and the Consultation Process
1 Day
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. Read More
Introduction to CE Marking for the In Vitro Diagnostics Directive
1 Day
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 on-going maintenance to achieve continued regulatory compliance throughout the lifecycle of the product. Read More
Application of the In Vitro Diagnostics Directive
3 Days
A three day course to explore the IVD Directive, gain a greater understanding of the requirements and thus 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 lifecycle. 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. Read More
