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 Training Services, ISO 13485 training course - Excel Partnership UK

ISO 13485 MEDICAL DEVICES




ISO 13485 TRAINING COURSES
Code Training Course Duration
Ex 120

Understanding ISO 13485:2002 Quality Standard for the Medical Device Industry
Provides a detailed overview of the new proposed standard and how the changes will affect a company's quality system, its control, and its 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

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

 

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