What you'll learn
Understanding the phases of medical device development
Medical device safety and compliance
How to train your staff on new medical device
Single - use medical device reprocessing
Development of medical device policies
Medical device regulation act
Home medical equipment

Requirements
No special requirement
Desire to learn more about medical device

Description
The purpose of a medical device is to benefit others and improve the quality of life. However, in order to keep patient and user risk at a minimum, authorities have tightened up regulations over recent years with the hope that manufacturers will build quality in, while taking risk out of a device. The growing complexity of medical devices requires more advance testing and certification to verify safety, performance and compliance to regulatory requirements. To effectively help patients, healthcare products need to be available. However, before these products are sold, they need to demonstrate safety and effectiveness. As the healthcare industry adapts to connected and evolving technologies, safety standards are always being updated. This makes new types of safety testing a must for today's healthcare products. It is very important to note that medical device manufacturers, developers and standards authors all look at the same safety issues when it comes to patient care, information access, data security, product safety and result reliability. Regulatory compliance for medical devices is difficult to navigate. Manufacturers, developers and end users often need assistance to stay on top of the latest trends and standards to keep their product compliant. Effective health technology policies address inequality as well as accessibility, affordability and availability of innovation and core medical devices required to target the health needs, particularly those that address the millennium development goals.