Quality System Regulations for Medical Devices

Delivered in-house, this 1-day practical workshop is designed to provide the latest information on the FDA’s Quality System Regulations for medical devices and related product safety requirements in the USA and demonstrate how companies wishing to sell their medical devices in the USA can meet these regulations.

This introduction carefully examines the requirements of the QSR and product safety in order to prepare companies for the design requirements.

• The FDA requirements and how they might affect an organisation.
• Implementing the requirements effectively so as not to affect other regulatory requirements.
• Locating key pieces of information within the appropriate documents (DHF, DMR and DHR).
• Review of related standards such as risk analysis and the applicable guidance documents.
• The relationship between QSR and the MDD/IVDD and ISO13485/ISO9001 requirements.
• The regulatory requirements for reporting incident/near incidents (MDR).
• Addressing 21 CFR Part 11 Electronic Signature and Records.
• Adding value to an organisation’s management system.
• Preparing for an FDA QSIT type audit.
• Sources of information and further development

• Executives and Senior Management
• R&D Managers/Engineers and Members of Design Review Teams
• RA/QA Managers and Management Representatives
• Members of multi-discipline Design Teams
• Sales and Marketing, Production, Shipping, MIS, Purchasing

By the end of this Quality System Regulations for Medical Devices training course, delegates will be able to:

• Interpret the requirements of QSR and its relationship with MDD/IVDD and ISO 13485/ISO 9001 requirements.
• Identify the methods for successful implementation of the Regulations
• Prepare for an FDA QSIT-type audit and add value to an organisation’s management system.

The Quality System Regulations for Medical Devices training course can occur at your premises, a venue of your choice or online. The course includes 10 modules and interactive workshops covering topics such as ‘Using QSIT’, ‘Overview of Medical Device Regulation in the EU’ and ‘The Requirements of QSR’ to allow your team to discuss how they will successfully implement methods and ideas learnt within your organisation.

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