The course covers the requirements of the Medical Device Regulatory Standard ISO 13485 and the regulatory framework and documentation required to market a medical device. Those attending will get an understanding of the requirements and documentation required to market and maintain compliance for medical devices in the market place. There are tutorials on the Directives, the regulatory system, the marketing of a device, and the ISO 13485 Medical Device Standard. Added to this, there is an introduction to risk management and the vigilance system. The course is interactive with many practical exercises and discussions.

Suitability

GMP for medical devices is the perfect course for people who are new to the medical device industry, the diagnostics sector, or those working in the pharmaceutical industry where medical device regulations are applied - e.g., for inhalers, pre-filled syringes, infusion bags, etc.

Learning Outcomes: At the end of the course you will:

• Understand the regulatory framework of medical device manufacture and marketing
• Understand the ISO standards and how they are used in the approval process
• Have knowledge of the tools used in risk assessment and vigilance systems

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