Preparing for FDA Medical Device Inspections – The Requirements



2 days


Virtual Learning


About This Course

Recognizing what to expect during an FDA inspection enables a medical device manufacturer to effectively prepare for the inspection. This instructor-led two-day course is designed to prepare domestic and foreign medical device manufacturers doing business or intending to do business in the United States to recognize and prepare for FDA pre- and post-market inspections.

This course focuses on identifying FDA inspection criteria, resources (including key standard operating procedures such as CP 7382.845) and practices used to plan, conduct, and assess inspections of medical device manufacturers.

Key Learning Objectives

On completion of this FDA medical device inspections course, you will be able to:

  • Identify key requirements of the FDA’s Quality System (21 CFR Part 820) and Medical Device Reporting (21 CFR Part 803) Regulations
  • Recognize the intent of regulatory requirements as described in preamble discussions
  • Recognize key similarities and differences between 21 CFR Part 820 and ISO 13485:2016
  • Identify inspectional resources used by FDA investigators
  • Identify key elements/focus of FDA’s Quality System Inspection Technique (QSIT)

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.


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 FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.

Nanci Dexter - Nanci has over 35 years of experience in the medical device and IVD industries. Nanci has created numerous quality systems for small and medium-sized companies, conducted mock FDA and ISO13485 audits and authored many worldwide regulatory submissions. Her diverse experience ranges from auditing, leading compliance remediation projects, conducting regulatory strategies and holding regulatory and quality management positions in both the United States and Europe.

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.

Christine Brown - Christine has over 30 years of experience working with regulated medical device, combination products, and pharmaceutical manufacturers and FDA class I, II and class III devices. Her areas of expertise include Post Market Quality, CAPA), Quality Systems, Quality Management, Product Development, Production and Process Control, and External Agency Inspections (FDA-483, warning letter, and consent decree situations). She has been an expert witness and participant in the FDA 510(k) premarket applications under the FDA Accredited Person Program for medical devices, as a third party-reviewer. Christine holds a Bachelor of Science in Biomedical Engineering And holds certifications as a Certified Software Quality Engineer, Certified Reliability Engineer, and Certified Quality Auditor from the American Society for Quality in addition to being a certified Quality Systems Auditor for ISO13485:2016 and MDSAP.

Additional Recommended Courses

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

This virtual instructor-led two-day course covers the requirements of ISO 13485:2016, including the intent, meaning, and interrelationship of the ISO 13485:2016 clauses. This course will also introduce learners to ISO 13485:2016 Medical Devices – A Practical Guide. This guide was developed by ISO TC 210 (the developers of ISO 13485:2016) to assist medical device manufacturers in the practical application of the requirements of ISO 13485:2016 within a quality management system. Learners will demonstrate comprehension through individual and group activities throughout the course as well as a final course challenge.

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 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

Price: $1200.00

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

CAPA Considerations: Problem Statement Writing and Investigation Techniques

Utilizing proven methodologies, this highly interactive medical device CAPA writing course provides learners

with the tools and skills needed to identify root causes of existing nonconformities from complaints, process deviations, audits and other feedback mechanisms. 

This 2-day virtual instructor-led course covers how to effectively write concise, understandable problem statements and specific corrective action plans relative to problem statements. Learners are provided with instruction and guidance as they conduct hands-on medical device writing exercises, working through case studies of investigation data and summarizing key findings. Our highly experienced instructor will provide real-time feedback to help learners write concise medical device nonconformity statements.

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:

  • Define the purpose of Corrective and Preventive Action (CAPA)
  • Identify and analyze data inputs for CAPA
  • Compose a proper and complete problem statement
  • Apply investigation techniques to identify root causes and define the appropriate corrective action
  • Identify effectiveness criteria and perform an effectiveness check
  • Recognize how to close the CAPA loop and the requirements to close CAPAs in a timely and complete manner.

Price: $1200.00