ISO 13485 MEDICAL DEVICES
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| Code | Training Course | Duration |
|---|---|---|
| Ex 120 | Understanding ISO 13485:2002 Quality Standard
for the Medical Device Industry |
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 |
| Ex 125 | Design Control for the Medical Device Industry This two-day course provides the information needed to meet the required regulations driven by ISO9001, QSR, and the European Medical Device Directives. You will learn how to deal with the cultural and business issues that impact Design Control activities. |
1 Day Delivered in Company Only |