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ISO 13485:2016 Medical Devices Lead Auditor and Internal Auditor Trainings

Recognized by Exemplar Global

ISO-13485:2016-Training-Medical-Device

ISO 13485, MDSAP and FDA Lead and Internal Auditor Training

Why was ISO 13485 revised?

ISO 13485:2016 sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised to respond to the latest developments in quality management, technology and regulatory requirements that relate to the industry.

What does ISO 13485:2016 include?

With the standard applicable to so many types of products, the revision was no easy task. A medical device is any product intended for use in the diagnosis, prevention and treatment of medical conditions. They range from simple products like wound dressings to dentist chairs, cardiac pacers, life-support machines and even in vitro diagnostic reagents.

How is the new ISO 13485:2016 better?

Improvements in the new version of the standard include broadening its applicability to include all organizations involved in the life cycle of the product, from concept to end of life, greater alignment with regulatory requirements and a greater focus on post-market surveillance including complaint handling.

There is also a greater emphasis on having the appropriate infrastructure, particularly for the production of sterile medical devices, and more focus on risk management.

Read more on ISO.org

Early Bird Pricing

 

• $200 off- 60 Days in Advance

 

• $100 off- 30 Days in Advance

 

4-Day ISO 13485:2016 Lead Auditor with 21 CFR 820 - $1995 Recognized by Exemplar Global
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Quality Medical Device Management Systems Lead Auditor with ISO 13485:2016 and FDA 21 CFR 820

We teach you how to use auditing to improve your organization

 Days: 4 • CTUs: 3.6 • Price: $1995

Monday-Thursday  8:00 am – 6:00 pm

Each 4-day class covers:

  • Quality management principles
  • Standards and guidelines (including history of standards)
  • Interpretation of the latest revision ISO 9001
  • Interpretation of the latest revision ISO 13485
  • FDA 21 CFR 820
  • Documentation and records
  • Introduction to quality audit
  • Managing the audit process
  • Audit scheduling and preparation
  • Performing the audit
  • Reporting the audit
  • Corrective action and follow-up
  • Registration, Accreditation and Auditor Certification

The Workshops include:

  • Analyzing Processes to Identify Resources and Critical Controls
  • Analyzing Operational Risk
  • Reviewing System Documentation and Preparing an Audit Plan
  • Reviewing Processes and Preparing Checklists
  • Verifying Facts
  • Determining Nonconformities
  • Writing Nonconformity Statements
  • Interviewing Auditees
  • Chairing a Closing Meeting
  • Reporting the Audit
  • Taking Corrective Action


Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these EXEMPLAR GLOBAL knowledge competency units:

MD – Medical Device Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams

The Certificate of Attainment provides evidence of knowledge competency defined by EXEMPLAR GLOBAL for certification as a Medical Device Management Systems Lead Auditor.

Even though ISO 9001 and ISO 13485 are used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.

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Completion of this course satisfies the training requirements for certification by Exemplar Global as a lead auditor.

3-Day Internal Auditor ISO 13485 Course - $1595 Recognized by Exemplar Global
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Quality Medical Device Management Systems Internal Auditor with ISO 13485:2016

We teach you how to use auditing to improve your organization

 Days: 3 • CTUs: 3.6 • Price: $1595

Monday-Thursday  8:00 am – 6:00 pm

    Each 3-day class covers:

  • Quality management principles
  • Standards and guidelines (including history of standards)
  • Interpretation of the latest revision ISO 9001
  • Interpretation of the latest revision ISO 13485
  • FDA 21 CFR 820
  • Documentation and records
  • Introduction to quality audit
  • Managing the audit process
  • Audit scheduling and preparation
  • Performing the audit
  • Reporting the audit
  • Corrective action and follow-up

    The Workshops include:

  • Analyzing Processes to Identify Resources and Critical Controls
  • Analyzing Operational Risk
  • Reviewing System Documentation and Preparing an Audit Plan
  • Reviewing Processes and Preparing Checklists
  • Verifying Facts
  • Determining Nonconformities
  • Writing Nonconformity Statements


Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these EXEMPLAR GLOBAL knowledge competency units:

MD – Medical Device Management Systems
AU – Auditing Management Systems

The Certificate of Attainment provides evidence of knowledge competency defined by EXEMPLAR GLOBAL for certification as a Medical Device Management Systems Internal Auditor.

Even though ISO 9001 and ISO 13485 are used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.

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This course is delivered by Axeon in partnership with Quality Management International, Inc.  Successfully completing the course examinations satisfies the training requirements for certification by Exemplar Global as an internal auditor.

3 Day MDSAP & ISO 13485 Internal Auditor Class- $1595
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MDSAP & ISO 13485 Internal Auditor Class with ISO 13485:2016

MDSAP-ISO-13485-certified-auditor-training

We teach you how to use auditing to improve your organization

 Days: 3 • CTUs: 3.6 • Price: $1595

Monday-Thursday  8:00 am – 6:00 pm

Days: 3 • CEU Hrs: 2.4

Audience: Beginner to Advanced

 

Overview:

This course prepares you to perform internal QMS audits using industry-proven techniques and to apply proper interpretation of the ISO 13485 standard and MDSAP requirements to real life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting.  This is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.

This Internal Audit class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing and apply MDSAP and ISO 13485 requirements. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.

 

Who Should Attend

Individuals who will perform audits to regulatory requirements or Quality Management Systems, individuals assisting their organizations toward ISO 13485 registration or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.

 

Prerequisites

There are no required prerequisites, though familiarity with ISO, US, Australia, Brazil, Canada, and Japan quality system requirements for medical devices is helpful.  All attendees are required to bring their own copy of the ISO 13485 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.

 

Course Objectives

  • Prepared to conduct a solo internal audit at successful course completion
  • Understand the MDSAP audit model.
  • Understand and interpret the ISO 13485 requirements and review applicable MDSAP requirements.
  • Apply the proper interpretation of the standard in actual audit situations.
  • Understand process auditing tools leading to substantive quality system improvements
  • Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  • Follow-up and resolve “audit trails that present themselves during the audit interviews
  • Conduct audits that result in real improvements to the quality system
  • Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.

2-Day Risk Based Thinking and Risk Management ISO 31000 & 14971 Training - $1295
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2-Day Risk Based Thinking and Risk Management

ISO 31000 & 14971

Risk Management for ISO 9001:2015, AS9100:2016 and ISO 13485:2016

 Quality Risk Management Principles and Practices

This class will teach participants to turn Risk Assessment into a well-organized systematic approach that targets and then reduces risk to the organization, customers and stakeholders. While Risk Management is a requirement for Aerospace and Medical Device Manufacturers, these same techniques can be used regardless of the products or services offered by your organization.

 

Who should attend

  • Anyone who needs to develop and implement a comprehensive Risk Management
  • Program meets requirements for ISO 14971 and ISO 31000
  • Any organization that needs a formal, disciplined approach to the identification, assessment and management of Risk
  • Quality Managers
  • Engineering Managers
  • Internal and external auditors
  • Design Teams
  • Management Representatives
  • Project Teams
  • Anyone who needs to understand the difference between Risk Identification, Risk
  • Assessment and Risk Management and how to put these important tools to work for your organization.

 

What you will learn

  • The components of risk management that can be applied to any organization, regardless of their products or customers
  • How to design a risk management structure for your organization that gets results
  • A means for demonstrating to customers and stakeholders the potential risks associated with products or processes and provide assurance that these have been effectively managed
  • Tools used for Risk Assessment such as FMEA and FMECA
  • How to quantify risk as the first step in establishing priorities for your organization

 

Day 1 Agenda

  • Risk terminology and theory from ISO 14971,ISO 13485, and ISO 31000
  • History of risk management and relationship with Corrective and Preventive Actions
  • Requirements of ISO 14971
  • Design of framework for managing risk
  • 4.3.2 Establishing risk management policy
  • Integration into organizational processes
  • Establishing internal communication and reporting mechanisms
  • Establishing external communication and reporting mechanisms
  • Implementing risk management
  • Implementing the framework for managing risk & risk management process
  • Continual improvement of the framework
  • Communication and consultation
  • Establishing the internal and external context
  • Establishing the context of the risk management process
  • Defining risk criteria
  • Risk assessment
  • Risk identification
  • Risk analysis
  • Risk evaluation
  • Risk treatment
  • Selection of risk treatment options
  • Preparing and implementing risk treatment plans
  • Monitoring and review
  • Recording the risk management process
  • Exercises B.1 – B.6 internal & external framework, risk treatment, risk monitoring, risk policy, risk analysis
  • Additional Requirements for ISO 31000

 

Day 2 Agenda

  • Guidelines from ISO 14971/31000 Risk Assessment Techniques – Risk Management
  • Selection of risk assessment techniques
  • Selection of techniques
  • Availability of Resources
  • The Nature and Degree of Uncertainty
  • Complexity of risk
  • Application of risk assessment during life cycle phases
  • Types of risk assessment techniques
  • Flow charts and process mapping
  • Brainstorming
  • Risk Checklists
  • Delphi Method
  • Process FMEA
  • Design FMEA
  • Fault Tree Analysis (Event Tree Analysis)
  • HAZOP & HACCP
  • Cause & Effect with 5-Whys & 7-M
  • Preliminary hazard analysis
  • Risk Ranking and Filtering
  • Case Studies with application
  • Organization’s Risk Procedures and Tools
  • Case Studies from Organization’s Risk Analysis, Treatment and Monitoring
  • Risk Applications in the Aerospace organization
  • Internal Audit
  • Training
  • CAPA System
  • Supplier Selection & Control
  • Outsourcing – Special Processes
  • Facilities and Equipment
  • Design & Development
  • Production and Process Controls
  • Process Validation and Re-Validation
  • Servicing
  • Design FMEA Case Study
  • Various Risk Case Studies
  • Organization’s Case Studies
  • Statistical Methods
  • Test

 

2-Day Medical Device Regulation Overview - $1295
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Medical Device Regulation Overview

 

This course provides an overview of European Medical Device Regulation and the implications for company’s organizations.

   Background

Since the 1990s, regulation of the medical device industry in Europe has remained relatively unchanged. Recent incidents, including the breast implant crisis and the hip replacements, prompted urgent regulatory and compliance reforms to the Medical Device Industry. Among the most significant of these are the European Commission’s 2012 proposals for regulation on medical devices (EU MDR) and in-vitro diagnostics (EU IVDR).

National regulators exert more control and oversight of the medical devices industry—with adoption mandatory. Companies can lose their license to operate if they fail to comply with these upcoming changes.

   Medical Device Market

Manufacturers producing medical devices for the EU market today, and who want to continue supplying those devices beyond 2020, must comply with the new EU MDR. Most of the new requirements are really extensions to already existing requirements. In the majority of cases, these new requirements simply bring the EU regulations up to date with the medical device requirements in the rest of the world.

   UDI

Unique Device Identification or UDI is the bar-coding of all medical devices on the European market using a standard format. A database provides users and regulators quick access to information about the coded device.

The requirements for device classification in the new European Medical Device Regulation (EU MDR) are essentially the same as those in the current Medical Device Directive (MDD)

   Why This Training?

The impact of this regulation can dramatically alter the operations of medical device manufacturers.  It can even impact the composition of their existing as well as future portfolios. Cost of compliance is most likely significant. It is critical that
businesses take action now—to gain stakeholder buy-in, prepare their organisations, and start implementing changes.

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2-Day ISO 13485 Internal Auditor- $1295
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2-Day ISO 13485 Internal Auditor

Days: 2 • CEU Hrs: 1.9

Day 1: 7:30 a.m.- 5:30 p.m.

Day 2: 7:30 a.m.- 4:00 p.m.

Audience: Beginner to Advanced

 

Overview

This course prepares you to perform internal QMS audits using industry-proven techniques and to apply proper interpretation of the ISO standard to real life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting.  This is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.

This class teaches Internal Auditing for ISO 13485 Quality Management Systems.

This Internal Audit class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the ISO 13485 standard. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations. 

Who Should Attend

Individuals who will perform audits to ISO 13485 Standards or Quality Management Systems, individuals assisting their organizations toward ISO 9000 registration, or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.

Prerequisites

There are no required prerequisites.  This course is routinely taught to quality novices and life-time professionals. All attendees are required to bring their own copy of the ISO 13485 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.

Course Objectives

  • Prepared to conduct a solo internal audit at successful course completion
  • Fully understand and interpret the ISO 13485 requirements.
  • Apply the proper interpretation of the standard in actual audit situations.
  • Understand process auditing tools leading to substantive quality system improvements
  • Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  • Follow-up and resolve “audit trails that present themselves during the audit interviews
  • Conduct audits that result in real improvements to the quality system
  • Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.

 

Agenda

 

 Part 1: Introductions and Self-Assessment

  • Course requirements
  • How to get the most from this experience
  • Networking with class mates (industry professionals)
  • Self-assessment of audit skills and internal audit programs Exercise #1

 

Part 2: Quality Terminology and Definitions

  • Quality industry vernacular from ISO 9000, ISO 19011
  • Differentiating between Verification and Validation
  • Understanding Corrective and Preventive Actions
  • How to converse with external auditors
  • Terminology Exercise #2

 

Part 3: Requirements of ISO 13485

  • Demystifying the ISO 13485 standard
  • Interpreting and cross-referencing the quality standard
  • Analyzing audit findings
  • Audit exercises for application of ISO 13485 to quality events
  • Exercise #3-#7: Short case studies in quality events

 

Part 4: The Audit Process: Roles and Duties

  • Roles of Auditors, Auditees, and Management during Internal Audits (IAs)
  • Qualifying Auditors
  • Duties of the IA staff
  • Exercise #8: Preparing to be audited

 

Part 5: The Audit Process: Performing the Audit Process

  • Audit Tools – checklists, process maps, findings, reports
  • Conducting Audit Interviews Exercise #9
  • Exercise #10 Quality event case studies

 

Part 6: The Audit Process: Audit Skills and Techniques

  • Audit Interviewing techniques
  • Continual improvement techniques
  • Process Auditing methods
  • Developing a “continual improvement” attitude in the organization
  • Exercise #11 Writing Audit Findings
  • Exercise #12 Evaluating the effectiveness of Audits
  • Exercise #13 Application of Process Auditing techniques

 

Part 7: The Audit Process: Finalizing the Audit

  • Writing the audit report
  • Opening and Closing Meetings
  • Exercise #14 Writing and audit report
  • Exercise #15 Writing Non-Conforming Reports
  • Exercise #16 Conducting a Closing Meeting

 

Review and Examination for Certificate

 

2-Day Human Factors - $1295
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Human Factors – $1295

Days: 2 • 

 Day 1-2: 7:30 a.m.–4:30 p.m.

 

Course Description

Human Factors is a term that appears in the latest versions of several ISO standards, including:

  • ISO 9001:2015 General manufacturing QMS
  • AS9100D:2016  Aerospace QMS
  • ISO 14971:2007 Risk management for medical devices
  • ISO 45001:2018 Occupational health and safety

 

This course helps you to understand human factors in the context of each standard.  You will learn how to apply the concept of human factors to your management system and address the standard requirements.  You will also receive practical tools, proven methodologies, and helpful tips to make the job easier for you.

 

As will all of Axeon’s courses, this is a practical, how-to course that is not bogged down in academic discussions.  We use case studies, practice exercises, and learning activities to keep the training activities and build competence.

 

Who Should Attend?

Quality Managers, Managment Representatives, Quality Engineers, Safety Managers,  and Top Management

ALSO:   Quality Consultants, Those involved in performing corrective actions, Those involved in medical device risk management, and Regulatory Affairs Specialists

 

Prerequisites

None.  Our students range from seasoned quality professional to novices.  Our goal is to meet everyone at their current level of competence and increase it.

 

Course Objectives

  • Understand the requirements of human factors in the context of each standard.
  • Learn how to address human factors within your organization’s quality and/or safety management system.
  • Provide practical tools and methods for addressing human factors.

 

 

Course Syllabus

DAY ONE

Intro to Human Factors

Review ISO Standard Requirements: 9001, AS9100D, 14971, 45001

Definitions of Human Factors by Standard

 

Human Factors and Root Cause Analysis

Corrective Action and Human Factors

The 13 Most Common Human Factors

Activity: Applying Human Factors in Corrective Action

 

Human Factors and Poka-Yoke

Definition & History of Poka-Yoke

Methodology for Poka-Yoke

Activity: Applying Poka-Yoke to Human Factors

 

DAY TWO

Human Factors and Health & Safety

Definition of Human Factors in Health & Safety

Human Factors and Ergonomics

How Human Factors influence Safety at Work

Activity: Applying Human Factors to Safety

 

Human Factors and Medical Devices

Methodology for Considering Human Factors in Risk Assessment

Device Design According to Human Factors Consideration

Human Factors in Post-Market Surveillance

 

Final Test

 

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2-day EU MDR - $1295
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European Medical Device Regulation

(EU MDR)

The EU Medical Device Regulation (MDR) is far more complex than the Medical Device Directive (93/43/EEC) it replaces and presents new challenges. Strict new requirements for Clinical Data, risk management, postmark surveillance, and supplier management.

The EU MDR isn’t in effect until May 2020. Companies with limited resources and sizeable medical device portfolios often need help planning how and when to transition MDR.

The two-day course on the Medical Device Regulation 2017/745 with a focus on the requirements for Medical Device Manufacturers.

In this course, you will receive a general overview of the Medical Device Regulation, the Implementation Timelines, Paths to CE Mark, and a deep dive into the significant articles that affect medical device manufacturers.

Included in the presentation is a copy of the MDR, a gap analysis template, and a sample of the General Safety and Performance Requirements checklist with highlights of significant differences from the MDD Annex I Essential Requirements Checklist.

 

Agenda:

  • Overview of the Medical Device Regulation
  • Implementation timeline
  • Paths to CE Mark
  • Regulation structure overview
  • Review of Significant Articles
    1. In-Depth Review and Discussion of Articles
  • Review of Significant Annexes
    1. In-Depth Review and Discussion of Annexes
  • Strategy for Deployment
  • Significant Pitfalls to watch out for
  • Unknowns – Still to be determined
  • Tools and References

1-Day Transition for ISO 9001:2015, ISO 13485:2016, AS9100:2016 Course $950
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9001:2015 , 13485:2016, & AS9100:2016 Transition

Who Should Attend

Those responsible for planning and executing the transition from ISO 9001:2008 to ISO 9001:2015, including Management Representatives and Quality Managers, or anyone desiring an up-to-date awareness of the changes that will be impacting new or existing ISO 9001:2008-based Quality Management Systems, including ISO 13485 and AS9100.

Course Objectives

  • Understand the key changes to ISO 901:2015, AS9100 Rev D (2016), and ISO 13485:2016
  • Understand the development and implications of Annex SL
  • Learn how the new format and structure of 2015 sub-clauses compares to those of 2008
  • Provide tools, techniques and tips to address the new requirements for strategic planning, risk management, the context of the organization, etc.
  • Become aware of new requirements in documentation

Agenda

 

Day One

 

  • New Requirements of ISO 9001:2015, ISO 13485:2016, and AS9100:2016
  • Comparison of the Structure and Sequence of ISO 9001:2015 to ISO 9001:2008
  • Implications of Appendix 4
  • Strategic Planning Elements of 4.1, 4.2, 6.1, and 9.3
  • Risk-based Elements of 6.1, 7.5.1, and 8.1
  • Action Plan Elements of 6.2
  • Differences in Documentation and Other Requirements
  • Timetable for Transition of Certification to ISO 9001:2015 and AS9100:2016
  • Individualized Transition Road Map

 

1-Day Maximizing the ROI from your Quality Management System- $950
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Maximizing the ROI from your Quality Management System

1-day Managment Training

Days: 1

Schedule: 7:30-4:30 daily

Audience: Top management

Overview 

A Quality Management System is NOT a cost of doing business.  It’s an investment.  And top management should expect to get a financial return on that investment.  However, the Return On Investment (ROI) they receive will be greatly impacted by the level of leadership and commitment they provide concerning the management system.

The newest versions of most ISO management standards have amplified the requirements for top management, in accordance with ISO 9001:2015.  In this highly interactive course, senior managers will learn how to fulfill their new responsibilities, take accountability, and maximize the ROI they get from their management systems.

Who Should Attend

  • Top management from organizations with quality, environmental, or safety management systems, including chief executives, general managers, and other senior managers.
  • Quality Managers and/or Management Representatives are NOT the intended audience for this course, although they are certainly welcome.

 

Goals

To provide decision-makers with information that will help them to provide direction for their existing or planned quality management system

 

Learning Outcomes

  • Understand the new top management ISO requirements and how to accomplish them.
  • Understand the responsibilities that can be delegated to a management representative, and those responsibilities top management must retain.
  • Learn how to maximize the ROI from your management system.
  • Receive practical methods, tools, and tips for using your QMS to enhance organizational performance.
  • Learn the mistakes to avoid that can negatively impact your management system.

Couse Syllabus

Benefits of a Quality Management System

Overview of Potential Benefits, including Return on Investment (ROI)

Why Top Management Leadership and Commitment is Important.

Creating an Organizational Culture that Supports Quality.

 

Overview of Quality Principles

What is Quality?  What is Quality Management?

Top Management Responsibilities (per ISO 9001) and How to Accomplish Them.

How to Maximize the ROI from your QMS

ROI Depends on an Organization’s Level of Commitment to its QMS System.

Using your QMS processes to ensure Customer Satisfaction and Increase Profitability.

Using the Process Approach to Manage Quality (Turtle Diagram).

Establishing KPIs and Determining Process Effectiveness.

Continuously Improving your QMS.

Reducing the Costs of Poor Quality (COPQ).

Using Your QMS to Manage Risks and Support Your Strategic Direction.

The Five Biggest Mistakes Executives Make with Quality Management

Final Test

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