Preparing for FDA Medical Device Inspections – Practical Guidance

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

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

Understanding what to expect during an FDA inspection enables a medical device manufacturer to prepare effectively for an FDA inspection. This 16 hour 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 identifying and understanding FDA’s inspection criteria, resources, and practices used to plan and conduct inspections of medical device manufacturers. This course is designed to benefit your organization’s quality professionals responsible for managing and facilitating FDA inspections; as well as those responsible for defining, documenting, implementing, and maintaining an effective quality management system.  

Learning Objectives

At the end of this course, students will be able to:

• Identify key requirements of FDA’s Quality System (21 CFR Part 820) and Medical Device Reporting (21 CFR Part 803) Regulations
• Recognize the intent regarding Regulatory Requirements as described in preamble discussions
• Recognize key similarities and differences between 21 CFR Part 820 and ISO 13486:2016
• Identify inspectional resources used by FDA Investigators
• Identify key elements/focus of FDA’s Quality System Inspection Technique (QSIT)