ISO 13485 MEDICAL DEVICES

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For Clinical and Testing Laboratories, see ISO/IEC 17025
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ISO 13485 TRAINING COURSES
Code	Training Course	Duration
Ex 120	UNDERSTANDING ISO 13485:2003 QUALITY STANDARD FOR THE MEDICAL DEVICE INDUSTRY Provides a detailed overview of the Standard and the process approach to managing a company's quality system, its control and effectiveness..	1 Day Delivered In Company Only
Ex 121	QUALITY SYSTEM REGULATION (QSR) FOR MEDICAL DEVICES, CGMP 21 CFR Part 820 Carefully examines the requirements of the Quality Systems Regulations (QSR) and product safety, compares the requirements of QSR with MDD/IVDD, prepares companies for the design requirement, and provides the methods for successful implementation of the regulations.	1 Day Delivered In Company Only
Ex 122	INTERNAL AUDITOR TRAINING FOR THE MEDICAL DEVICE INDUSTRY Complying with FDA and CE Marking Requirements (ISO 13485/9000 and QSR) Introduces auditing as a powerful management tool in establishing an organization's effectiveness in controlling the quality variable, and discusses certification audits so you can begin preparation for FDA/Notified Body audits.	2 Days Delivered In Company Only
Ex 123	RISK ANALYSIS FOR MEDICAL DEVICES Provides understanding of the risk analysis standard for medical devices ISO 14791 and how to use it.	1 Day Delivered in Company Only
Ex 123	RISK ANALYSIS/FMEA FOR MEDICAL DEVICES Provides understanding of risk analysis and how it applies to medical devices; develops the skills necessary to apply risk analysis methodologies, such as FMEA, to medical devices.	2 Days Delivered in Company Only
Ex 124	UNDERSTANDING THE EUROPEAN DIRECTIVE 93/42/EEC concerning Medical Devices Provides a detailed overview of the Directive and later changes and the relevance to Medical Device Manufacturers. This Directive provides the 'rules of the game' in manufacturing CE marked medical devices and it is important that these are understood by all Medical Device Manufacturers. Regulatory Bodies and their roles are defined in the Directive, together with classification criteria and the routes to the EC Declaration of Conformity and the use of the CE mark.	1 Day Delivered in Company Only

Excel Partnership provides full ISO 13485 Training Services which includes a significant proportion of workshops, case study programmes and simulation exercises as part of the ISO 13485 training course.

ISO 13485 MEDICAL DEVICES