Designed for people who are new to the medical device industry, diagnostics or are
working in the pharmaceutical industry where medical device regulations are applied,
such as inhalers, pre-filled syringes, infusion bags etc. The course covers the requirements
of the Medical Device regulatory standard ISO13485 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.
working in the pharmaceutical industry where medical device regulations are applied,
such as inhalers, pre-filled syringes, infusion bags etc. The course covers the requirements
of the Medical Device regulatory standard ISO13485 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.
