The 4 Best Medical Device Quality Assurance Training Options

Organizations spend $12 billion a year on quality assurance, which seems like a lot until you learn they lose twice that amount on issues related to poor quality control.

A good medical device quality assurance program means you’re less likely to experience adverse events, you can address any issues that arise in clinical trials quickly, and you can get your device to market with confidence.

However, poor quality assurance training can lead to loss of revenue, potential fines from regulatory bodies, and more. If your organization is losing potential revenue due to direct quality costs such as internal failures or remediation, it’s necessary to take action. Evaluate whether training, hiring a QMS consultant, and/or better technology is the best path forward.

Better quality assurance is a huge competitive advantage and an insurance policy against costly quality losses for organizations who are willing to invest in a proactive approach. Quality assurance training and medical device training programs can improve skills and knowledge at your organization and allow you to drive quality improvements throughout the medical device lifecycle. If your QA team could benefit from updated, expert knowledge, the following QA courses are designed specifically for medical device organizations.

1. ASQ ISO 13485 Courses

American Society for Quality (ASQ) is among the largest global quality organizations, offering membership, conferences, certification, and training to organizations in quality-driven industries. Their course catalog includes several course offerings for QA professionals in the medical device industry, including both web-based and in-person options. Several listed options suitable for beginning to intermediate practitioners include:

ISO 13485 Requirements A–Z

This 20-hour web-based course, which costs $389 (or $350 if you’re an ASQ member), offers rolling enrollment and the ability for students to complete the course at their own pace within 180 days of purchase. The coursework is designed to help “auditors, supervisors, and managers in the medical device industry” understand and interpret each component of ISO 13485. With your fee, you’ll get a textbook, downloadable handouts, online access to ISO 9000, and a certificate of completion. Access to the course expires after 180 days.

ISO 13485:2016 Foundations

This live virtual course is ideal for anyone who wants to gain a deeper understanding of the ISO 13485 audit process in the medical device industry. It’s led by an instructor over the course of either 4-hour sessions spread throughout four days or two days with 8-hour sessions. For 2022, it’s offered in February and April. Either session is $895, or $795 for ASQ members.

Attendees will have online access to materials for 90 days, starting five days before their session begins. During the session, students will learn about medical device QMS terms, intent and requirements of ISO 13485:2016, and more.

If you’re interested in taking a deeper dive into auditing, there are other courses like ISO 13485:2016 Certified Lead Auditor, ISO 13485:2016 Certified Internal Auditor, and ISO 13485:2016 Internal Auditor (Medical Devices Quality Management System Training).

ASQ offers the unique value of global recognition as a leader in quality. Students can expect interactive exercises, quizzes, and peer networking opportunities. While their offerings are likely best targeted toward beginning and intermediate learners, their coursework offerings are the most affordable and flexible of all the options available.

2. AAMI Professional Development

The Association for the Advancement of Medical Instrumentation® (AAMI) is a non-profit community dedicated to safety in the device industry. AAMI focuses on standards development and continuing education through certification courses, conferences, and free online resources. Some of the courses they plan to offer in 2022 include:

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements

In this course, attendees will not only learn how to develop, but also maintain, a quality system program that aligns with FDA 21 CFR 820 and ISO 13485:2016. Students will also learn the differences between 21 CFR 820 and ISO 13485:2016 and will learn what the FDA and other regulatory bodies expect to see during an inspection. This course is virtual and conducted via Zoom sessions. The $3,570 fee includes a textbook, copies of regulations, PowerPoint presentations, the Quality System Compendium, case studies, relevant resources, and access to the exam. Throughout 2022, the course will be offered in January, April, August, and December.

Design Control Requirements: Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485

The draw for this course is that participants will learn directly from FDA representatives about design control requirements and how to evaluate a design control system for compliance. The course is three days and is virtual via Zoom. Once the course is completed, students should have the information they need to evaluate noncompliance issues and how to figure out ways to fix those issues so that the system is compliant with FDA regulations as well as ANSI/AAMI/ISO 13485 requirements. The $2,730 fee covers a textbook, PowerPoint presentations, case studies, and more. You can take the course in 2022 in February, May, September, or November.

If you register for one of their virtual courses, AAMI asks that you allow one week of time within the United States to receive any course materials and two weeks outside of the U.S. For any questions regarding their quality systems course offerings, contact education@aami.org.

Related Reading: What An ISO 13485 Quality Manual For Medical Devices Should Look Like

3. NSF Medical Devices Training

NSF International is an independent, accredited organization dedicated to the development of standards, certification, and training in industries that are impacted by regulatory requirements and safety standards.

NSF offers several eLearning course options that can be completed at the student’s pace. One medical device training program that may be beneficial for quality assurance professionals is their five-course bundle on medical device regulatory requirements and the Medical Device Single Audit Program (MDSAP) in major markets like the United States, Japan, Brazil, Australia, and Canada. The course bundle is offered at $1,400 and is 10 hours in length. Other medical device training programs they offer include:

• China Medical Device Regulations: Learn about pre-market and post-market regulations in China for both domestic and overseas manufacturers. After the 2-hour class, students should know the differences in China’s medical device regulations, recognize changing trends, and much more. This course is $399.99.
• FDA Medical Device Reporting Requirements: This 90-minute course, priced at $299, reviews who needs to report adverse events to the FDA, how to report those events, what types of events should be reported, and the timeframe in which to report them.

NSF also offers the option of customized on-site training on ISO 13485:2016, which can be scheduled on-demand for group training of QA and quality-involved colleagues, including quality directors, managers, engineers, and auditors. Pricing and travel details are not published on the website, and organizations should contact NSF for additional insight into live ISO 13485 training. NSF Medical Device Quality Assurance auditor training is unique among the leading options because it’s flexible and can be scheduled at your organization. Physical NSF training could be the right option for your organization if you need to train multiple staff members and external stakeholders, such as suppliers.

Related Reading: What is the Best ISO 13485 Quality Management System Software?

4. Compliance Online Medical Devices Regulations Training

The Center for Professional Innovation and Education (CfPIE) is a globally recognized name in training services for life sciences professionals, focusing on providing training and certification options to professionals in the pharma, biotech, and medical device industries. The organization offers a robust array of options for medical device quality assurance training, including dedicated training specialists who can provide individualized advice according to budget, professional needs, location, and other variables. Organizations with 10 or more interested employees can schedule an on-site certification program in medical device quality.

CfPIE is offering virtual training in 2022 for medical device professionals, including a course titled “Good Clinical Practices (GCP) & Risk-Based Monitoring – Understanding and Implementing Current Global Requirements” in March and November. The three-day course is suitable for industry professionals involved in the design and implementation of a global compliance program and risk-based quality systems. The course fee is $2,650 unless you take advantage of the early-bird registration and sign up 30 days in advance for a $200 discount.

Other medical device training courses offered by CfPIE span many topics, including risk management, FDA regulations and compliance, European Union regulatory issues, and much more.

A Free Medical Device Quality Assurance eBook

Investing in QA training can protect your organization against the direct and indirect costs of poor quality, including internal quality failures, rework, or the risks of delayed time-to-market. There are many quality training options available from organizations dedicated to improving skills and knowledge in the field, which range from self-paced introductory courses to highly advanced, topical training that requires physical attendance.

Quality is an enormous competitive advantage in the medical device industry. Research shows the highest-performing organizations all use a quality management system (QMS) to implement a culture of quality across the entire product lifecycle. To learn more, download our free eBook: 9 Ways to Improve Quality in Medical Device Product Development