Modern Medical Device Development

Phases of medical device development, Medical device safety and compliance, How to train your staff on medical device.

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.