ISO 13485 Training
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by Kelmac Groupbased in IRELAND
This course aims to provide learners who have an existing, basic knowledge of, or experience in, quality management in the Medical Device Industry and in the context of the requirements of ISO 13485, compatible with ...
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by EuroQuestbased in USA
standard from an auditor’s perspective, highlighting the changes from the former version. In addition, the concepts of ISO 14971 - The Medical Device Risk Management Standard - will be ...
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by IMSM Ltdbased in UNITED KINGDOM
ISO 13485 specifies requirements for a Quality Management System for organisations required to demonstrate its ability to provide medical devices that consistently meet client and regulatory ...
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based in USA
When medical device nonconformities occur, peoples' lives are often at stake. Consequently, the medical device industry is one of the most heavily regulated, and product and process compliance is a primary objective for all quality management systems for medical ...
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based in USA
You'll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 ...
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based in USA
13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical ...
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based in USA
Are you already familiar with ISO 13485:2003/EN 13485:2012 and want to find out about ISO 13485:2016? This comprehensive course introduces you to the new requirements and explores the changes between ISO 13485:2003/EN 13485:2012 and the latest standard. With ...
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based in USA
This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, the European Medical Device Directives and US FDA's Quality System Regulation. The relationship with ISO 14971 “Application of Risk Management to ...
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based in USA
Are you an existing auditor with knowledge of ISO 13485 wishing to update your audit programme in line with ISO 13485:2016? This course will refresh your auditing techniques and help you prepare to audit against requirements. With a transition period of 3 years, it's important to get up to speed so you can ensure your ...
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based in USA
As a leader, your commitment and support is crucial to the success of your organization's ISO 13485:2016 Medical Devices Quality Management System (QMS). This interactive briefing has been designed around the requirements of the standard and highlights your responsibilities in terms of leadership and commitment. The focus is on helping ...
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based in USA
Computer system validation and risk-based verification and validation planning to meet US FDA and ISO 13485 ...
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based in USA
With greater attention on the organization's ability to meet applicable customer and regulatory requirements, the new ISO 13485:2016 focuses on the entire supply chain of the medical device industry, with added emphasis on risk management. Discover the latest requirements and explore the changes since ISO 13485:2003 and EN ...
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based in USA
will also understand how ISO 14971 applies to ISO 13485. The training includes exercises, and participants will have the chance to ask questions about how ISO 14971 and risk management apply to their ...
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based in USA
and risk management efforts. Participants will also understand how ISO 14971:2007 apply to ISO 13485:2003. The training includes exercises, and participants will have the chance to ask questions about how ISO 14971:2007 and risk management apply to their organizations. Particular focus is on the changes to the 2007 version and ...
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based in USA
Global Manager Group offers various ISO training programs to help businesses gain ISO standard certification. We provide genuine training consultancy believing in customization and providing company specific training programs. Our training fees never exceed your budget thus assuring quality training opportunities for all companies. We offer ...
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Manufactured by Covartimbased in BELGIUM
We are here to support our clients but also to strenghten their team. We aim at helping them become autonomous and take control of their progression. For this purpose our specialists have developed a comprehensive training program on key ...
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based in USA
This package of 5 training courses is meant to give an exhaustive and in-depth understanding of the Japanese Pharmaceutical Affairs Law (PAL) including the 2005 revisions which are now in ...
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Manufactured by Penlon Limitedbased in UNITED KINGDOM
Penlon offers a wide range of product specific Service Training Courses to ensure that its products are installed and maintained ...
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based in USA
ComplianceOnline has created these courses individually through world renowned experts and combined them together to create a comprehensive training resource for companies to train their employees. You can store it as a library material and train all your employees in these compliance issues to get them ready to face any kind of compliance challenge and overcome it through expert advice and best ...
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based in USA
This Medical Device Software Development & Management package training will have 4 courses which covers FDA's Medical Device Software Regulation, Medical Device Software Verification and Validation, IQ / OQ / PQ Approach and IEC ...
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