ISO 13485: 2016 Medical Devices: Requirements

Level Requirements Duration 1 day

Available to book: Public classroom Book Now

Discover ISO 13485 quality management and how it can improve your medical devices business.

Our Understanding ISO 13485 Medical Devices course provides an overview of quality management system requirements.

Find out how the standard impacts the design, development and production of medical devices – improving quality and efficiency. And learn why ISO 13485 compliance is essential to meeting customer and legal requirements.

Take the first steps towards your own medical devices quality management system, drawing links with other quality standards including ISO 14971 medical device risk management.

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- Understand the importance of complying with ISO 13485
- How to meet the requirements of ISO 13485
- Define ISO 13485 roles and responsibilities
- Understand the relationship between ISO 13485 and ISO 14971
- Senior management
- Regulatory, quality, design, development, manufacturing and marketing managers and teams
- Organizations preparing own branding or private labelling for devices
- Training course notes
- Lunch and refreshments
- Certificate

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