Modern Medical Device Development

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.
Overview
Section 1: Introduction
Lecture 1 Introduction
Lecture 2 What is medical device
Lecture 3 IS0 13485
Lecture 4 What is the medical device development process
Lecture 5 Medical device regulation act
Lecture 6 Standardization and regulatory concerns
Lecture 7 Packaging standards
Lecture 8 Common challenges that prevent medical device from getting onto the market
Lecture 9 Single- use medical devices
Lecture 10 Global medical device nomen clature
Lecture 11 Medical software
Lecture 12 Home medical equipment
Lecture 13 Biomedical engineering
Lecture 14 Health technology
Section 2: Understanding 5 Phase Of Medical Device Development
Lecture 15 Phase 1: Initiation,opportunity and risk analysis
Lecture 16 Phase 2: Formulation,concept and feasibility
Lecture 17 Phase 3: Design and development verification and validation
Lecture 18 Phase 4: Final validation and product launch preparation
Lecture 19 Phase 5: Product launch and post market surveillance
Section 3: Medical Device Safety And Compliance
Lecture 20 Element for evaluation
Lecture 21 Confidence through compliance
Lecture 22 Compliance and safety solution
Section 4: Single Use Medical Device Reprocessing
Lecture 23 Single - use medical device reprocessing
Lecture 24 The single use label
Lecture 25 Safety and efficacy of reprocessed SUDs
Lecture 26 International regulation of single- use medical device reprocessing
Section 5: How TO Train Your Staff New Medical Device
Lecture 27 Benefits of medical device training
Lecture 28 What to accomplish in medical staff training sessions
Lecture 29 Set training goals
Section 6: Development Of Medical Device Policies
Lecture 30 Development of medical device policies
Nurse, doctors, health workers, health consultants, students, specialist, companies, hospitals, regulatory agencies, governments, insurance companies, general public, business people etc.

Homepage

https://www.udemy.com/course/modern-medical-device-development/

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