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Learn the basic requirements in the ISO 13485:2016 training for medical devices. Understand the key areas to use a risk based approach, important terms, mandatory documents needed, and more!
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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.
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
Benefits from taking the PathWise ISO 13485 course include:
- A downloadable checklist of all required documents to audit your organization
- A list of all key terms and definitions used within the regulation
ISO 13485 online training is for those individuals involved in the design, production, auditing, installation and servicing of medical devices.
The ISO 13485 online training module is worth 0.1 CEU credits.
PathWise is accredited by the International Association for Continuing Education and Training (IACET). PathWise complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, PathWise is accredited to issue the IACET CEU.
Learners must complete the following in order to earn CEU credit:
- Verify your electronic signature
- Complete the full course module on ePath
- Complete the full instruction module
- Complete the post course assessment on ePath with an 80% score or better (learner will be given 2 opportunities to take the assessment).
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