What you will learn
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Gain in depth knowledge of ISO 13485: 2016 and its key requirements and how it relates to medical device regulation
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Gain a fundamental understanding of the effects of ISO 13485 QMS compliance on product quality
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Appreciate the importance of establishing an effective Quality Management System (QMS)
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Acquire the basics of good documentation practices
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Understand Risk Management principles and how managing quality, safety and efficacy risks helps ensure patient safety referencing to current ISO 14971 standard.
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Familiarize with requirements enforced by Regulatory Authorities such the European Medicines Agency, the Singapore Health and Sciences Authority (HSA), etc.
Target Audience
This course is suitable for all job roles within the medical device industry, including for those who are looking to gain entry into this industry. These include organisations involved in one or more stages of the life cycle of medical device, including design and development (D&D), production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, warehousing, production, packaging, labelling, or quality control/quality assurance; or if you're in a role providing associate services or materials to such organizations (raw materials, parts, filters, packaging materials, or consumables).
Course Facilitation and Duration
This course can be run as a two-day live classroom or virtual (synchronous) instructor-led training. Please contact us for details.