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Kelmac Group Limited
Raheen Conference & Business Centre Pearse House
Raheen Business Park
Limerick
Ireland
P: +353 61 491 224
F: +353 61 491 225
E: info@kelmacgroup.com
ISO 13485, ISO 14971
Auditor and Implementation Training
Medical Devices Management Systems
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
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
Internal QMS Auditor based on ISO 9001:2008 and ISO 13485:2003
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
QMS Auditor/Lead Auditor based on ISO 9001:2008 and ISO 13485:2003 (A17133)
This 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
If you do not see the course you require or require further details on our Training courses, please complete our Enquiry Form.
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