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Modern Medical Device Development
Rating: 4.1 out of 5(5 ratings)
16 students

Modern Medical Device Development

Phases of medical device development, Medical device safety and compliance, How to train your staff on medical device.
Created byEric Yeboah
Last updated 5/2026
English

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
  • How to sterilize medical instruments
  • Key procedures for ensuring equipment hygiene

Course content

8 sections32 lectures2h 33m total length
  • Introduction2:19
  • What is medical device5:34
  • IS0 134855:51
  • What is the medical device development process8:11
  • Medical device regulation act3:29
  • Standardization and regulatory concerns8:49
  • Packaging standards1:45
  • Common challenges that prevent medical device from getting onto the market6:50
  • Single- use medical devices9:33
  • Global medical device nomen clature6:54
  • Medical software9:24
  • Home medical equipment6:04
  • Biomedical engineering2:42
  • Health technology9:34

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. Health in general requires good hygiene, and one of the best hygiene is to ensure proper cleaning of the medical equipment after usage.

Who this course is for:

  • Nurse, doctors, health workers, health consultants, students, specialist, companies, hospitals, regulatory agencies, governments, insurance companies, general public, business people etc.