Iso 13485: Medical Devices Qms Certification Masterclass

Learn ISO 13485 from scratch for medical devices development, production, storage and distribution or installation

What you'll learn
Learn all ISO 13485 characteristics including the specific procedures, documentations, regulatory requirements and risk management
The role of ISO 13485 2016 in the United States and EU regulation system.
Learn the Active Implantable Medical Device Directive 90/385/EEC.
Understand realization of a medical device, with reference to various types of processes and products in the industry
ISO 9000:2000: Quality management systems
Supply chain management and activities of medical devices
Identifying and Implementing the Quality Management System for medical devices
Planning quality objectives of product realization
Learn Quality policy, Quality objectives, Realization process, Requirements and Effectiveness for medical device manufactoring
Master planning of the realization of the medical device and building a Quality Plan
Validation and Verification Activities
Evaluation criteria of design and development of medical devices
Building device history record (DHR) and device master record (DMR)
Control of production service and service provision
Requirements
No prior experience required
The course is suitable for everyone with desire to learn Medical Devices Quality Management
Description
This course is a complete step-by-step certification guide to ISO 13485.  ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activitiesRequirements of ISO 13485 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.Section 1 Scope: This section reviews the ISO 13485 Standard’s aims and concepts and defines the scope of application of the standard to your quality management systemSection 2 Normative References: The meaning and purpose of the normative references is to indicate that terminology and nomenclature specified in this standard is not open for debate or an interpretive discussion.Section 3 Quality Management System: This section provides the general requirements and main principles of a quality management systems. This section is a foundation for self-evaluation of whether the organization’s quality management system follows the general requirements.Section 4 Management Responsibility: This section lays out the requirements of top management regarding the quality management system. It specifies the principle that will construct the commitment of top managementSection 5 Resource Management: Resources are one of the foundation stones of the quality management system. The standard requires us to define, manage, and control our resources. The standard relates to three kinds of resources: human resources, infrastructures, and work environment. These are responsible for critical areas and scopes of the realization processes, especially when it comes to medical devices.Section 6 Product realization: The section initiates the master planning of the realization of the medical device and refers for the first time to the term “quality plan”. Planning of this will cover the entire life cycle of the medical device.Section 7 Measurement Analysis and Improvement: The objective of the measuring processes is to collect, analyze, and report data that are relevant to the medical devices and realization processes. The analysis shall strive to support the processes and maintain the effectiveness of your quality management system, as well as the quality of the medical devices

Overview

Section 1: Introduction

Lecture 1 Introduction

Section 2: Scope of ISO13485 Standard

Lecture 2 General Scope

Lecture 3 Application

Section 3: Terms and Definitions

Lecture 4 Terms and Definitions

Section 4: Quality Management System

Lecture 5 General Requirements

Lecture 6 Documentation Requirements

Lecture 7 Quality Manual

Lecture 8 Control of Documents

Lecture 9 Control of Records

Section 5: Management Responsibility

Lecture 10 Management Commitment Requirements

Lecture 11 Customer Focus

Lecture 12 Quality Policy

Lecture 13 Planning

Lecture 14 Responsibility and Authority

Lecture 15 Management Reoresentative

Lecture 16 Internal Communication

Lecture 17 General

Lecture 18 Review Input

Lecture 19 Review Output

Section 6: Resource Management

Lecture 20 Provision and Resources

Lecture 21 Human Resource

Lecture 22 Competence, Awareness and Training

Lecture 23 Infrastructure

Lecture 24 Work Environment

Lecture 25 Human Resources Health

Section 7: Product Realization

Lecture 26 Planing of Product Realization

Lecture 27 Verification of the Product

Lecture 28 Customer Related Processes

Lecture 29 Review of Product Requirements

Lecture 30 Customer Communication

Lecture 31 Design and Development of Planning

Lecture 32 Design and Development of Inputs

Lecture 33 Design and Development Outputs

Lecture 34 Design and Development of Review

Lecture 35 Verification Requirements

Lecture 36 Design and Development of Validation

Lecture 37 Control of Design and Development Changes

Lecture 38 Purchasing Process

Lecture 39 Purchasing Information

Lecture 40 Verification of Purchased Product

Lecture 41 Control of Production and Service Provision

Lecture 42 The Use of Monitoring and Measuring Devices

Lecture 43 Control of Production and Specific Requirements

Lecture 44 Installation Activities

Lecture 45 Service Data Information and Report

Lecture 46 Particular Requirements for Medical Devices

Section 8: Measurement, Analysis and Improvement

Lecture 47 Measurement, Analysis and Improvement

Lecture 48 Monitoring and Measurement

Lecture 49 Internal Audit

Quality Assurance Specialists,Quality Assurance Engineers,Project Managers,Research and Development Professionals,Verification and Validation Professionals,Process Development Engineers,Business Owners looking to implement ISO 13458,Operation Professionals,Business Students and Graduates,Professionals working with in ISO 13485, QSR ISO 9001, 21 CFR 820,Six Sigma and Quality Control Professionals