ISO 13485

Training overview
Professional Course
Self-paced Online
1 hour
From 295 USD

Start dates
295 USD
Virtual instructor led training available

Course description

ISO 13485

ISO 13485 is an important regulatory standard created by the International Organization for Standardization (ISO). It is important for organizations involved in the design, production, installation and servicing of medical devices and related services. As regulatory requirements become more demanding, and the life science industry becomes more complex, the standard can help organizations create a more compliant, effective, and efficient quality management system. The PathWise ISO 13485 training for medical device manufacturing online course covers outlines key areas, including the emphasis on risk management and risk-based decision making.

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Training content

After taking the ISO 13485 training for medical device manufacturing, learners will be able to: List areas required to use a risk-based approach, Define key terms used in Quality Management Systems for medical devices, Identify mandatory documentation for ISO 13485, Describe topics covered during management review meetings, Classify required resources for product conformity, Summarize the product realization process, Explain the importance of internal audits, Label sources of non-conformances and improvement


295 per person, corporate rates available

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About PathWise


In a globally regulated life science industry, PathWise provides proven methodologies in quality and compliance through hands-on and practical solutions that ensure compliant, effective, and efficient quality systems. PathWise focuses on a solutions-based approach to solving client issues. We help...

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