ISO 13485:2016 - Fundamentals -Medical Devices - QMS - Requirements for Regulatory Purposes

Dates

Times

2 days

Location

Virtual Learning

Availability

About This Course

This instructor-led two-day course covers the requirements of ISO 13485:2016, including the intent, meaning, and interrelationship of the ISO 13485:2016 clauses.

Key Learning Objectives

At the end of this training, learners will be able to:

  • Identify key documents to help you understand ISO 13485:2016
  • Recognize the primary elements of ISO 13485:2016
  • Identify terms and definitions relative to the application of ISO 13485:2016
  • Recognize similarities and differences between ISO 13485:2016 and the Quality System Regulation
  • Demonstrate practical application of ISO 13485:2016 requirements through inspection scenarios

Who Should Attend

This course is vital for any medical device professional, including regulatory and quality directors, managers, engineers, and auditors, who is responsible for implementing or working within a quality management system in accordance with ISO 13485:2016. This is a global standard, so it is applicable to devices intended for the market in any jurisdiction around the world.

Tutors

Course tutors selected from the following:

Robert Ruff - Rob has over 30 years’ experience in the medical device and public health sectors, including completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). He also developed the FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.

James Pink - James Pink has over 20 years of experience in the medical devices industry, including 10 years as a health care technology expert and lead auditor for a prominent European notified body. He began his career as a product designer in the oil tools industry before moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assurance programs for active and nonactive implantable and combination products. Mr. Pink is a contributor to several medical device standards committees, including ISO 13485, ISO 14971 and various product-related standards.

Janet Book - Janet Book has worked in the field of quality for the past 35 years in a wide variety of industries, including blood banking, food processing, quality consulting, chemical, pharmaceuticals and medical devices, she has conducted internal and supplier audits utilizing many different industry-specific standards, due diligence evaluations as well as capability assessments. She has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing quality management systems; and developing and presenting quality-related training and seminars. Janet is a certified Six Sigma Black Belt and served as an adjunct professor at Carnegie Mellon University. Recently, she earned her Certificate in Privacy Law and Cyber Security and worked in privacy providing guidance on quality, regulatory and compliance functions. She is a senior member of the American Society for Quality (ASQ), an ASQ Certified Quality Auditor (CQA), an ASQ Certified Quality Engineer (CQE), an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and an RABQSA Quality Systems Lead Auditor.

Gert Sorensen - Gert Sorensen has worked in the field of Medical Device quality for the past 22 years in different roles; as a QA specialist within global companies producing class I, II and III Devices also including electronics and software. Gert has also worked as a consultant specialized in FDA 21 CFR compliance, Process Validation and Software Validation and as Notified Body Auditor. Gert has conducted internal audits, supplier audits and third-party audits under ISO 9001 and 13485, MDD 93/42/EEC, MDR 2017/745 and MDSAP. He has also conducted due diligence evaluations as well as capability assessments. He has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing global quality management systems; and developing and presenting quality-related training and seminars.

Ashley Kelleher - Ashley has more than 14 years of professional experience in the medical device, pharmaceutical and certification industries. Her experience includes program management and project management of global, third-party, and notified body certifications for the medical industry. In addition, Ashley has expertise in reviewing technical file documentation (CE marking) and holds lead auditor certifications for ISO 13485, GDP, MDSAP, EU-MDR, ISO 14971, ISO 9001, and ISO 15378. Her educational background is in veterinary science.

Additional Recommended Courses

Preparing for FDA Medical Device Inspections – Practical Guidance (Advanced)

Understanding what to expect during an FDA inspection enables a medical device manufacturer to prepare effectively for an FDA inspection. This course is designed to meet the needs of domestic and foreign medical device manufacturers doing business or intending to do business in the United States. This course focuses on group activities designed to identify the key elements of Level 1, 2, 3 and For Cause inspections; preparing for and hosting an FDA inspection; review FDA databases (MAUDE and Recall) to identify and understand the focus of an FDA For Cause inspection; review the preamble and QSIT Guide to understand how to prepare for an inspection of the primary subsystems contained in QSIT; develop effective FDA 483 responses; and prepare in advance information needed by the investigator to complete an EIR (as described in the IOM). This course is designed to benefit your organization’s quality professionals responsible for preparing for, facilitating, and responding to FDA inspections; as well as those responsible for defining, documenting, implementing, and maintaining an effective quality management system.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Identify key elements of FDA’s Quality System Inspection Technique
  • Recognize the types of FDA inspections
  • Recognize key activities and responsibilities relative to hosting an FDA inspection
  • Identify pre-inspectional databases (e.g. MAUDE, Recall) used by FDA Investigators in preparation for FDA inspections and their utility
  • Identify key elements of an effective FDA 483 response
  • Prepare (in advance) key documents and information required to be included in an FDA Establishment Inspection Report (EIR)


Who should attend
This course benefits quality professionals responsible for managing, facilitating, and participating in FDA inspections, as well as those responsible for defining, documenting, implementing, and maintaining an effective quality management system.

This course is important for medical device professionals, especially those who conduct or participate in any project and/or quality management system activity.

Price: $1200.00

Writing Effective Nonconformity Statements During Medical Device QMS Audits

This virtual instructor-led one-day course will introduce you to the importance of writing effective nonconformity statements during medical device manufacturer quality management systems audits.

This course covers the fundamentals of medical device QMS auditing that influence the writing of effective nonconformity statements; and how to recognize when to communicate nonconformities during an audit; and identify tools and tips for writing effective nonconformity statements.

In addition, learners will apply the concepts covered during the course through practical application. Working in groups, learners will review multiple nonconformity scenarios, develop nonconformity statements relative to the scenarios and participate in instructor-led analysis of the nonconformity statements.

This course pairs well with CQI IRCA-certified QMS Lead Auditor based on ISO 13485 2016 and MDSAP Requirements, EU MDR Internal Auditor (2 day), EU IVDR Internal Auditor (2 day), and MDSAP Internal Auditor Training (2 day).

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Identify useful techniques to apply when writing effective nonconformity statements
  • Review fundamental terminology important to writing effective nonconformity statements including audit, objective evidence, audit criteria, and nonconformity
  • Evaluate the use of the acronym FOCAL as a tool for developing an effective nonconformity statement.
  • Apply the three key principles when writing a nonconformity statement


Price: $800.00

ISO 14971:2019 Risk Management for Medical Devices and IVDs-Practical Application

ISO 14971:2019 provides guidelines for manufacturers to establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks associated with the identified hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is an integral part of a manufacturer’s quality management system.

This virtual instructor-led two-day course presents the key foundations of the risk management process defined in ISO 14971:2019 and provides expert tips on how to navigate the process including review of TIR 24971:2020.

This course is highly interactive and includes practical instruction, case study exercises and a competency assessment.

This course also includes a self-paced two-hour ISO 14971:2019 overview eLearning module that must be completed prior to the start of the live instruction.

This course pairs well as a prerequisite to Design Controls for Medical Devices and IVDs (2 day).

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Identify regulatory requirements for risk management:
    • European Regulation EU 2017/745 (EU MDR)
    • European Regulation EU 2017/746 (EU IVDR)
    • 21 CFR 820.30(g)
  • Identify requirements of key International Standards relative to risk management:
    • ISO 14971:2019
    • ISO 13485:2016
  • Recognize risk management definitions and principles
  • Identify how risk management affects quality management system practices
  • Recognize one method for the practical application of risk management principles


Who Should Attend
This course is vital for any medical device professional looking to expand their knowledge on comprehensive risk management processes and explain their interactions with the entire lifecycle of a medical device from conception to decommissioning and disposal.

Price: $1200.00