Medical Devices Awareness Training

Introduction to Medical Devices

This introductory training course will provide you with sound information of medical devices, classes, classifications, and an understanding of ISO 13485. There are millions of medical devices available in the world today, with 600,000 in the UK alone. From sticking plaster to life support machinery and everywhere in between, you would have a selection of thm in your home, car, boat and office. They are found in aircraft, factories, dental surgeries, operating theatres, diagnostic scanning departments, laboratories, pharmacies and emergency vehicles such as ambulances.

What's inside?

In this course you will discover:

• What medical devices are
• Categories and classifications
• The required regulations
• The Quality Management System
• Management requirements
• Product realisation, measurement, analysis and improvement
• Differences between ISO13485 and ISO9001

Who is it for?

If you are functioning within a licensed premises of any kind and engaging Good Distribution Practice while handling medical devices, this is for you. The regulations do not permit the handling, storing and supply of medical equipment of any kind to a wholesaler, pharmacy (and end user i.e., the patient) outside of GDP or GMP (Good Manufacturing Practice, if you are manufacturing them). It is required in law that you are trained and certificated as competent to be part of the supply chain for medical devices.

What will I get out of knowing more about medical devices?

As already mentioned, you cannot legally handle medical devices in the supply chain while you are not trained and certificated as competent in Good Distribution Practice. By the end of this course, you will have an understanding of what is expected from ISO13485, a heightened awareness of care for the medical devices in your charge and therefore, a greater sense of patient safety responsibility. You would also be better briefed in procedure for the processing of medical devices. Procedures such as the quarantining of contaminated, damaged or potentially counterfeit medical devices is largely the same as handling pharmaceutical products and medicines: Your entire role in the supply chain is to look after the end-users, who are the patients themselves. The certification you receive is acceptable to inspectors as evidence of training, and of course it is a weighty addition to your personal curriculum vitae. General information can be found in the European GDP Guidelines (2013/C 343/01).