ISO 13485, ISO 14971, Process Validation, Quality System Regulation 21 CFR Part 820, Design Control, Software Validation, EU MDD/CMDR Training
ISO Auditor, Implementation, Medical Devices, QSR/QSIT Training
Effective quality management systems are recognized as a key regulatory consideration for allowing medical device manufacturers to market their products around the world.
Understanding ISO 13485
Kelmac Group's Understanding ISO 13485 training course gives delegates a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485 requirements.
Duration: 1 day
Availability: Public/Open Training and In-House
Understanding ISO 14971 (Risk Management)
This course provides a thorough introduction and interpretation of ISO 14971 risk management, throughout the product lifecycle, including a summary of the latest changes to the standard.
Duration: 2 days
Availability: Public/Open Training and In-House
Internal QMS Auditor based on ISO 9001:2008 and ISO 13485:2003
Through small group activities, audit role-plays, lively discussions, and instructor-led lectures, delegates gain a thorough understanding of the principles of auditing. Delegates also learn how to apply the guidance of ISO 19011.
Duration: 2 days
Availability: Public/Open Training and In-House
EU Medical Devices Directives and Canadian Medical Devices Directives (CMDR)
An overview one day course covering both the EU Medical Device Directives and Canadian Medical Device Regulations(CMDR)
Duration: 1 days/p>
Availability: Exclusively In-House
Quality System Regulation 21 CFR Part 820
An intensive two day training course on how to establish and improve compliance with the Quality System (QS) Regulation which contains the GMP requirements for medical devices
Duration: 2 days
Availability: Public/Open Training and In-House
Process Validation
An intensive one-day training course on how to establish and improve compliance with the GMP requirements for process validation
Duration: 1 day
Availability: Public/Open Training and In-House
Medical Device Design and Development Control
An intensive one-day training course on how to establish and improve compliance with the GMP regulations for medical device design and development.
Duration: 1 day
Availability: Exclusively In-House
Validation of Medical Device Software
An intensive 2 day course on requirements for validation of medical device software as contained in EN (IEC) 62034
Duration: 2 days
Availability: Exclusively In-House
Implementing a QMS based on ISO 13485
Experienced instructors with real life experience explain how to build a successful management system and integrate it into the current business framework, prepare for, and achieve ISO 13485 registration.
Duration: 2 days
Availability: Exclusively In-House
Certified Systems Implementer (CSI) - ISO 13485 for the Medical Devices Industry
It is a structured programme that provides each delegate with the core knowledge and skills required by today's management system practitioner. This training is specifically designed to be very practical and hands-on so that delegates, once they successfully complete this course, can go on to lead and drive business focused stand-alone or integrated management systems within their respective organisations.
Duration: 9 days classroom plus 400 hours private study/project work
Availability: Public - starting September 2011
IRCA Certified QMS Auditor/Lead Auditor based on ISO 9001:2008 and ISO 13485:2003 (A17133)
This IRCA Certified comprehensive five-day course provides hands-on training to ensure that your lead auditor thoroughly understands the role and acquires the expertise needed to perform it effectively.
Duration: 5 days
Availability: Public/Open Training and In-House
If you do not see the course you require or require further details on our Training courses, please complete our Enquiry Form.
Equally if you would like a training quote please complete the following form.
€1,395/Person-
07 March 2012
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07 March 2012
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26 March 2012
