Managers, Team Leaders, Line Managers, Superintendents, OE Champions, Quality and Project Managers, Supervisors, Executives, Internal and External Auditors, Members of IT Team, Health & Safety Managers, Risk Managers, Business Process Owners, Business Finance Managers, Business Risk Managers, Regulatory Compliance Managers, Project Managers, Continuity, Risk, Quality, IT and Environmental Managers, Anyone involved in the system development, implementation and maintenance, Regulatory Affairs Managers, Consultants, Anyone who is involved in

ISO standards, Anyone involved in defining, planning, or implementing an ISO 13485 based quality management system, Anyone involved in the medical field, Professionals from the medical device industry wanting to gain a comprehensive knowledge of the main processes of MDQMS, Staff involved in the implementation of the ISO 13485 standard, Expert advisors in quality management for the medical device industry, Managers responsible for implementing MDQMS

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system. This course enables participants to learn about the best practices for implementing and managing medical devices quality management system (MDQMS) as specified in ISO 13485:2016. The participant will learn the different components of a MDQMS such as quality manual, required procedures, records, measuring performance, management commitment, internal audit, management review and maintaining effectiveness. You will be able to:

• Use ISO 13485:2016 as the basis for a QMS for medical device manufacturers
• Understand the relationship between ISO 13485:2016 and European Medical Device Directives
• Use ISO 13485:2016 as the basis of regulatory requirements worldwide
• Take the first steps towards ISO 13485:2016 certification
• Understand how you can better meet customer and regulatory requirements leading to increased patientsafety
• Find ways to increase efficiency and cost savings through quality management
• Monitor supply chains to achieve continuous improvement
• Develop safe and effective medical devices
• Motivate employees through CPD

This interactive Training will be highly interactive, with opportunities to advance your opinions and ideas and will include;

• Lectures
• Workshop & Work Presentation
• Case Studies and Practical Exercise
• Videos and General Discussions

• Objectives of the initiative
• Introduction to medical devices quality management system (QMS) concepts as required by ISO 13485
• Normative frameworks and methodologies related to quality and medical devices
• Fundamental principles of quality and medical devices
• ISO 13485 certification process
• Detailed presentation of the clauses 4 to 8 of ISO 13485
• Planning and Initiating an ISO 13485 audit
• Fundamental audit concepts and principles
• Audit approach based on evidence
• Preparation of an ISO 13485 certification audit
• MDQMS documentation audit
• Conducting an opening meeting
• The challenge for top management
• Explain the structure and scope of the ISO 13485 management system standard
• How ISO 13485 applies to the organization aiming for regulatory compliance worldwide
• Compare the requirements between ISO 13485 and ISO 9001
• Describe the implementation process
• Produce a project plan for implementation
• Identify and justify the resources required for implementation
• Eight quality management principles
• Overview of ISO 13485:2003 requirements
• Overview of ISO 13485:2003 requirements – Clause 4
• Overview of ISO 13485:2003 requirements – Clause 5

• Overview of ISO 13485:2003 requirements – Clause 6
• Overview of ISO 13485:2003 requirements – Clause 7
• Overview of ISO 13485:2003 requirements – Clause 8
• Facilitate development of processes, policies, objectives, documentation and measurement techniques
• Prepare for ISO 13485 certification
• Interpret the clauses of ISO 13485 using ISO 14969:2005
• Recognize the role and responsibilities of management in ISO 13485
• Recognize the relationship between ISO 13485 and ISO 14971
• Appreciate the use of ISO 13485 as the basis of Medical Device Regulations worldwide
• Introduction to ISO 13485:2003 audit trails
• The relationship of risk classification of medical devices to QMS requirements
• Risk classification rules
• Risk classification names
• Using accredited ISO 13485 certification in practice
• Communication between stakeholders
• Communication during the audit
• Audit procedures: observation, document review, interview, sampling techniques, technical verification, corroboration and evaluation
• Audit test plans
• Formulation of audit findings
• Documenting nonconformities

BTS attendance certificate will be issued to all attendees completing minimum of 80% of the total course duration.

Request Info

Salutation MR Miss ENG DR

Full Name*

Designation

Company*

Country * Egypt Saudi Arabia Ireland UAE France Turkey Bahrain South Africa Nigeria Oman Nethersland United Kingdom Malaysia Kuwait Online Indonesia Qatar Morocco Jordan Switzerland Singapore Spain Italy Uganda

City * Cairo Mansoura Ireland Abu Dhabi Riyadh Dubai Istanbul Manama Abuja Paris Kuala-Lumpur Amsterdam Muscat Salalah Jeddah Dammam Cape Town London Kuwait Online Indonesia Doha Casablanca Marrakesh Singapore Geneva Zürich Amman Barcelona Rome Marbella Milan Uganda Scotland Madrid Jakarta

Email*

Enquiry*

Captcha*

Enter Captcha*

Submit