The cost of quality in the medical device industry is probably even higher than you think.
The global impact of medical device quality assurance and failures is $36 billion, according to a recent study by McKinsey & Company, or between 7-9% of the industry's total sales revenue. Organizations collectively spend $12 billion on quality assurance and lose $24 billion on issues related to poor quality control.
Better quality assurance is a huge competitive advantage and an insurance policy against costly quality losses for organizations who are willing to invest.
Quality assurance training can improve skill and knowledge at your organization and allow you to take a more proactive approach to drive quality improvements throughout the medical device lifecycle. But how do you know which medical device QA training options are the best? As a team of medical device Quality Management System (QMS) specialists, we know which options are the most up-to-date and which are worth your time and financial investment.
5 Great Medical Device Quality Assurance Training Options
There’s an extraordinary shortage of skilled medical device quality assurance professionals with the knowledge to drive quality improvements in organizations. The McKinsey study revealed that medical device organizations with approved products typically spend 2.1% of their annual sales on routine internal quality failures, and experience 150% higher rework costs than equivalent organizations in less-regulated manufacturing industries.
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. If you determine 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
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:
This 20-hour web-based course 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 and how it differs from ISO 9001.
This 7-hour virtual course is explicitly designed for the needs of QA professionals who are involved in the active implementation of an ISO 13485 QMS. The course addresses internal auditing, process-based documentation, process validation, risk management, and corrective action. Prerequisites include QMS experience and active involvement in ISO 13485 implementation, and the cost does not include a required $200 copy of the standard. While the course is virtual, it relies heavily on peer collaboration and virtual classroom activities.
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 towards 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.
AAMI University offers courses held approximately once per month for active quality practitioners which require physical attendance. Several upcoming courses held in Arlington, VA include:
- May 7-9, 2019: Regulatory Requirements for Software Validation
- June 18-19, 2019: CAPA Requirements and Industry Practice
- July 30-August 1, 2019: Integrating Risk Management into the Product Lifecycle
The cost of attending these in-person trainings is $2,435 for employees of organizations that are not AAMI members. The government employee rate is $950.
AAMI offers very in-depth topical training for QA professionals seeking advanced knowledge in subjects during their monthly, topical 20-hour courses. These options are likely well-suited for experienced QA professionals. When travel costs are added to course registration fees, the cost of AAMI training can be high compared to alternatives--especially if your organization is located a significant distance from Arlington, VA.
3. NSF Medical Devices Training
The NSF is an independent, accredited organization dedicated to the development of standards, certification, and training in industries which are impacted by regulatory requirements and safety standards. NSF offers the option of a one-day, 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 also offers eLearning options which can be completed on-demand at the student’s pace. This includes a course bundle of Medical Device Regulatory Requirements which addresses compliance in major markets and the NSF’s single audit program. This 10-hour eCourse is priced at $1,400.
NSF Medical Device Quality Assurance auditor training is unique among the leading options because it’s flexible and can be scheduled at your organization. While pricing is not published online, 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.
4. Compliance Online Medical Devices Regulations Training
Compliance Online is a fully digital portal dedicated to the distribution of resources for compliance professionals. One unique offering is a ten-course pack, The Top 10 Medical Device Regulations. Purchasing the course provides an organization with full licensing rights to a packet of 10 CD ROM disks and accompanying PowerPoint slides, allowing the unlimited use of the coursework for group training or self-paced training among a QA staff of several team members.
According to the course description, the topics covered in this 17-hour course include mHealth, raw material risk management, QMS training, validating spreadsheets, and FDA regulations. The course was priced at $1,199 at the time of writing.
This option could be useful for organizations who are hoping to provide flexible, on-demand education options to a QA staff of several employees. Compliance Online didn't note when this content was recorded to provide context around whether the content is up-to-date, and no user-generated reviews of the course content are available.
Related Reading: What is the Best ISO 13485 Quality Management System Software?
5. CfPIE Medical Device Training Courses
CfPIE is a globally recognized name in training services for life sciences professionals, focusing on providing training and certification options to professionals in pharma, biotech, and the 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 currently has several dozen physical trainings scheduled for medical device professionals, including a course titled “Good Clinical Practices (GCP) & Risk-Based Monitoring - Understanding and Implementing Current Global Requirements" scheduled October 21-23, 2019 in Boston, Massachusetts. This 2.5-day course is suitable for industry professionals involved in the design and implementation of a global compliance program and risk-based quality systems. The cost of the training is $2,650 excluding travel and accommodation, with a $200 discount available to organizations who register by September 21, 2019, or earlier.
Many of CfPIE's upcoming courses are advanced and topical, such as multi-day courses in "Advanced Blockchain Concepts for Medical Devices" and "Auditing and Qualifying Suppliers and Vendors." While the costs of attendance including travel can be high, the course content could be uniquely valuable to experienced medical device QA who are seeking to expand expert technical skill sets.
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 the free eBook: 7 Things You Can Do Now to Improve Quality in Medical Device Product Development.