Medical Device Training Mastery Bundle. Save $785!

Bundle includes

Here are all the products that are included in your bundle.

Risk Management

Is it for you?

This course discusses how risk management is applied in the medical device and in vitro diagnostic (IVD) industries. Topics delve into risk management concepts and tools, including hazard identification, hazard analysis, fault tree analysis, failure modes and effects analysis (FMEA), Hazard Analysis and Critical Control Point (HACCP), mitigation application, regulatory requirements, the creation of risk management plans, reports and files, how to conduct Risk Management Reviews, and what might be audited in your Risk Management System.

Course Objectives

By the end of the course, you'll be able to conduct risk management for a variety of products, processes and services within the medical device industry and beyond.

  • Develop an understanding of Risk Management as part of the product and process development cycle by defining a hazard, levels of risk, types of harm, and to rank risk mitigation activity
  • Prepare a Hazard Analysis including hazards, hazardous situations, harms, and understand risk estimation
  • Perform a HACCP (Hazard and Critical Control Points) analysis as a qualitative process hazard analysis for process risk management for any process
  • Perform and assess the application and results that critical tools of quality such as a Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA) can provide
  • Compose and document mitigations to risk in a suitable regulatory format
  • Enumerate the fundamental documentation requirements of ISO 14971 (Medical Devices – application of risk management to medical devices)
  • Prepare a Risk Management Plan in a device, a diagnostic product, or a process, which describes the tasks involved in successfully leading an ISO Quality System implementation project from start-up through Registration
  • Apply structured qualitative and quantitative risk management concepts and tools leading to a documented Risk Management Plan and Risk Management File that can be used in any due diligence for reducing risk in product, process or service development

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Software Validation

Is it for you?

This Medical Device Software V&V course is critical for all software testers, quality engineers, and regulatory professionals working in the Medical Device and Healthcare industries. Learn the crucial elements of IEC 62304, ISO 14971, 21 CFR § 820.30, FDA General Principles of Software Validation, and other applicable international and regulatory standards as they apply to software testing activities and deliverables.

You will work on a assignments based on a real medical device, designed to help you determine software level of concern, software safety classification, define a software verification & validation plan, and write a software verification & validation summary report.

Overall, you will learn how to create these types of artifacts while also learning the regulatory requirements and expectations for software used in the medical device industry.

Course Objectives

  • Identify the different types of software regulated by the FDA and interpret the latest FDA regulations, guidelines and International standards applicable to medical device software. 
  • Discuss software level of concern and use it to focus validation activities and develop an appropriate validation strategy. 
  • Explain the different requirements for validation of device, manufacturing & quality system software and discuss how to differentiate between verification and validation in software testing.

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Human Factors and Usability Engineering

Is it for you?

Learn how to apply user-centered design and UX throughout the design process to make medical technology safe, effective, usable, and satisfying for clinicians and patients. Improve the quality of healthcare and prevent injuries and deaths due to medical error.

The training is for everyone involved in improving the usability or user experience of medical device products and/or software. UX designers, product managers, software developers, user acceptance testers, including those with no prior medical device experience. will benefit from learning this proven process.

Course Objectives

  • Define the role of human factors in the medical device design process
  • Understand appropriate human factors methodologies for the development of medical devices
  • Identify human factors standards relevant to medical device development
  • Review human factors documentation against the standards and process
  • Discuss human factors engineering requirements
  • Identify usability issues related to product design

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