Course Overview
This interactive good manufacturing practice training 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.
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.
About the Tutor
Lisa Banwell is an experienced, technically qualified Quality and Regulatory consultant, working in regulated industries, including Medical Device manufacturing, Pharmaceutical Analysis and Fine Chemical manufacturing.
She has specific experience in auditing, inspection management, Competent Authority communication and regulatory strategy and registration; her expertise spans infusion products, contact lens products, single use sterile medical devices, neurophysiological and vascular diagnostic/monitoring equipment.
Interested in attending? Click here to find out more information
