ONLINE COURSE
Specialization Program in Software as a Medical Device
A practical and complete training designed for professionals involved in the development, quality, or regulation of medical software.
What will you learn?
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You will learn the classification of medical devices.
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You will understand the requirements and updates of ISO 13485:2016 and the key principles of risk management according to ISO 14971.
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How to implement a quality management system according to regulations.
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How to identify, assess, and control risks during the life cycle of a medical device.
How to manage residual risk and the importance of the benefit-risk balance. -
How to implement proper documentation and risk management processes.
The life cycle of medical software according to ISO 62304. -
The difference between software verification and validation.
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The main regulations that apply to medical software, like ISO 14971 and EN 62304.
- Content
- Target audience
- Details
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Content
Module 1:
Quality Management System for medical devices according to ISO 13485
Module 2:
Risk management for medical devices according to ISO 14971
Module 3:
Medical Software Validation -
Target audience
- Professionals in the medical devices and healthcare products sector
- Companies that manufacture, install, or distribute medical devices
- Staff interested in learning the requirements of the ISO 13485:2016 standard
- Professionals who need to understand and apply ISO 14971 to meet regulatory requirements and improve patient safety
- Quality and risk management teams
- People responsible for the regulation and documentation of medical devices
- Managers and technicians in healthcare product quality
- Software developers for medical devices
- Technicians and managers responsible for validating healthcare products
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Details
Schedule: flexible, you set the pace.
Accessibility: available 24/7 for 60 calendar days from the date of purchase.
Included material:
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Module assessment test
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Training presentation in PDF
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Diploma / Certificate of attendance (downloadable from the same platform)
Payment by Bank Transfer: if you prefer to purchase this training via bank transfer, send us an email at academy@ambit-iberia.com
Billing: if you need an invoice in your company's name, enter all the details when purchasing the training, after "complete purchase," and the Ambit Iberia administration team will send it via email after the purchase.
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