Are the employees in your medical device manufacturing company skilled enough to produce qualitative and safe products?
Do you have any evidence to ensure their competency?
These two questions often trouble manufacturing companies a lot. Medical device training is a regulatory compulsion that the FDA and international governing bodies impose on manufacturing companies in the USA, ensuring the development of reliable products.
Companies like you not only have to train employees but also have to show that you have trained them effectively, making them compliant. The lack of effective training procedures is considered among the FDA-issued 483 observations, which can have severe consequences. But who should you train?
How can you provide evidence to comply with medical device regulatory bodies?
In this blog, we will answer all your questions related to medical device training and regulatory compliance.
Laws Regulating the Importance of Medical Device Training
Certain laws mandate the requirement of medical device training in the medical device manufacturing industry. According to these laws, it is essential to create procedures to identify employee training needs and ensure training effectiveness.
These laws include:
FDA Quality System Regulation (QSR)
Certain laws mandate the requirement of medical device training in the medical device manufacturing industry. According to these laws, it is essential to create procedures to identify employee training needs and ensure training effectiveness.
These laws include:
FDA 21 CFR Part 820 outlines the QSR for medical device manufacturing companies. In terms of personnel training requirements, the QSR allows medical device companies to define their methods for meeting requirements.
However, it also requires:
⦿ Employees are to be trained according to the Standard Operating Procedure (SOP) for their tasks.
⦿ Have proof of specialized training (if required) like welding.
⦿ Employees detecting defects must have specific training for that role.
⦿ Companies to determine general and job-specific training needs.
⦿ Each SOP is to have a training record and each employee is to maintain a personal training log.
ISO 13485
The ISO 13485:2016 Clause 6.2 Human Resources also states specific personnel training requirements in medical device manufacturing companies. According to ISO 13485 training, you must ensure personnel affecting product quality are competent based on their education, training, skills, and experience. You must also document the procedures of establishing competence, providing training, and ensuring personnel awareness.
Furthermore, you must:
⦿ Determine the necessary competence for quality-related roles.
⦿ Provide training or actions to achieve/maintain competence.
⦿ Evaluate the effectiveness of these actions.
⦿ Ensure personnel understand the importance of their activities and their impact on quality objectives.
⦿ Keep records of education, training, skills, and experience.
ISO 14971
ISO 14971 is an international standard for the management of medical device-related risks. It outlines how to identify, evaluate, and control risks throughout the product life cycle. Regulatory bodies like the FDA and the European Medicines Agency (EMA) often ask medical device manufacturing companies to comply with ISO 14971 guidelines.
According to the ISO 14971:2019 4.3 Competence of Personnel, organizations must ensure training.
For ISO 14971 training, you must:
⦿ Ensure risk management personnel are competent based on education, training, skills, and experience.
⦿ Provide continual training to stay updated with industry standards and changes.
⦿ Educate employees on risk analysis, evaluation, control, and post-production monitoring.
⦿ Emphasize the importance of documentation and traceability in risk management.
⦿ Tailor training programs to specific roles and responsibilities.
⦿ Ensure designers understand risk analysis and mitigation as well as production staff focus on risk control.
⦿ Train employees on regulations and standards aligned with ISO 14971.
⦿ Ensure staff understand the integration of ISO 14971 with other quality management standards.
⦿ Foster continuous improvement in risk management practices.
⦿ Encourage feedback and updates to training programs based on industry and regulatory changes.
Importance of Medical Device Training
There are several reasons why medical device training is important. Below, we are going to discuss these benefits.
⦿ Competency: Training helps in creating a team of competent employees who can produce high-quality work that meets medical device regulatory standards. Neglecting training can result in improper knowledge and application of processes and regulations.
⦿ Regulatory compliance: Documenting employee training is crucial to ensure compliance with FDA medical device regulatory standards.
Purpose and Scope of Medical Device Training
Medical device companies establish policies and processes for all the stages in the product development lifecycle, ensuring the development of a safe and usable medical device.
However, employees managing the different stages of the product development lifecycle must understand and effectively follow those policies and procedures.
That leads to quite some questions including:
When should you conduct a Medical Device Training?
Whenever a new document, policy, process regulation, or standard is established for ensuring the quality of medical devices, you must provide proper training to make your employees competent for implementing them in your process.
Who requires Medical Device Training?
According to FDA QSR 820.25(b), employees must undergo adequate training to perform assigned responsibilities effectively. Therefore, the FDA medical device regulatory standard states that training should focus on QMS basics and the specific regulations relevant to each person’s role, rather than training everyone on everything.
The following table shows the different organizational sections and their relevant FDA QSR and ISO 13485 training requirements.
What are the Various Medical Device Training Approaches?
There are two types of training approaches that medical device manufacturing companies can follow based on their company size, effectiveness considerations, employee skill levels, and operational risks related to product safety:
Manual Training Approach
Automated Training Approach
Manual Medical Device Training Approach
In this approach, companies need to determine and document training activities manually. Companies often rely on Excel, SharePoint, and even paper for training tracking and recording. These documents usually contain certificates/certifications to be awarded, course duration, course name, instructor/trainer, list of personnel attending the course(s), meeting place, meeting time(s), and meeting type (in-person or online).
The manual (also known as standard or traditional) training approach can be easily started and rolled out. However, with the increase in departments, employees, and processes, managing this hand-made list becomes difficult. People who face challenges with the manual medical device training approach include:
Trainees:
⦿ Going through a lot of documentation becomes time-consuming and frustrating.
⦿ Training can become disorganized if handled manually, affecting learner experience.
⦿ Misplacing or inaccessibility to documents required can reduce the effectiveness of the training.
⦿ Re-skilling and training do not align with trainees’ schedules.
Trainers:
⦿ Maintaining numerous spreadsheets, identifying candidates in need of training, and tracking training progress details become difficult.
⦿ Defining necessary skills for team members becomes complicated.
⦿ Pushing trainees to complete massive paperwork becomes tiring and time-consuming.
⦿ Managing spreadsheets with large volumes of data can be difficult.
⦿ Measuring employee performance post-training becomes challenging.
⦿ Checking compliances becomes energy-draining.
Executives:
⦿ Insufficient training leads to poor knowledge and quality outcomes.
⦿ Hindering staff competence and safety.
⦿ Risking brand reputation and compliance for being unable to support training.
⦿ Balancing thorough internal training with speed and efficiency is crucial for effective onboarding.
⦿ Difficulty proving the benefits of OEM-provided training due to a lack of proper metrics and analytics.
Manual Medical Device Training Approach
The automated medical device training approach tends to mitigate major challenges that you can face traditionally. It not only ensures effective regulatory compliance but also ensures competent team building and efficient operations. For automated medical device training, you can leverage a training management system (TMS) to streamline most of the processes.
A TMS is a crucial component of the QMS that major medical device manufacturing companies use. This system helps to establish processes on how to deliver information about device development to the stakeholders. Furthermore, it helps your Learning and Development (L&D) teams manage certifications, course schedules, and instructor rosters. There are other benefits that you can enjoy by automating medical device training processes with a TMS.
Benefits of Automating Medical Device Training
⦿ Centralized Training Data: A TMS stores all training-related information in one place. Therefore, trainees, trainers, and managers can easily access and manage records, certifications, and training materials.
⦿ Compliance Assurance: TMS helps ensure compliance with regulatory requirements. It tracks training completion, documentation, and certifications, reducing the risk of non-compliance issues.
⦿ Customized Training Programs: TMS allows the creation of tailored training programs based on job roles, skill levels, and compliance needs. Hence, it ensures that employees receive relevant and effective training.
⦿ Efficient Training Processes: TMS automates tasks such as scheduling, tracking progress, and sending reminders, saving time and reducing administrative burdens.
⦿ Enhanced Collaboration: TMS promotes collaboration among trainers, trainees, and managers. It provides communication tools, shared resources, and interactive learning features, creating an engaging and collaborative learning environment.
⦿ Performance Monitoring: TMS provides insights into training effectiveness and employee performance through analytics and reporting. Therefore, it enables organizations to identify areas for improvement and measure the impact of training initiatives.
⦿ Scalability: TMS can scale with the organization’s growth. It can accommodate increased training needs and expand user bases without compromising efficiency or compliance.
Medical Device Training within Quality Management Systems (QMS)
According to medical device regulatory standards, you not only have to train your employees but also have to document in your QMS and provide evidence of their effectiveness. Medical device regulatory auditors and inspectors will review this documentation and evidence to certify your product as a compliant and secure one.
So how are you supposed to document medical device training and provide evidence for it? Continue reading to know what you should document and assess to ensure compliance.
How to Document Employee Training?
Relying on a simple Excel sheet can lead to difficulty in documenting training for multiple employees. Therefore, most managers establish a set of training matrices that help them to:
⦿ Detect job-specific medical device training needs
⦿ Track completed training across departments
⦿ Provide evidence to auditors/inspectors related to training and competency tracking
However, the matrices will require individual employee records to prove employee competency after training.
What should you document for Medical Device Training Validation?
Auditors and inspectors access a list of documents to validate medical device training for employees. Let’s check out what they consider acceptable and unacceptable in the following table:
Training Types | Acceptable | Unacceptable |
In-person instructor-led group training | Certificate of completion/competency, employee sign-in sheet, or photocopies of individual attendance list | Attendee list without signatures |
One-on-one training between manager and employee | Individual attendance sheet signed by employee | Screenshot of online meeting invitations or personnel file notes |
Online training modules | Confirmation of completion or passing certificate issued by the learning management system (LMS) or proof of CEU credit | Registration confirmation email or notice |
SOP/work instructions emailed to an employee | Not acceptable as proof of training | Not acceptable as proof of training |
Third-party instructor-led (eLearning, in-person, or virtual training) | Completion/ competency certificate or CEU credit proof | Registration confirmation email or notice |
Dos and Don’ts for Medical Device Training Management
The difference between good training and bad training can be found after the production of medical devices. Good training can lead to effective and safe medical products while bad training can deliver defective and harmful ones.
Good medical device training ensures a skilled team that can produce and market quality products in the least possible time. It will also enhance your brand reputation in the eyes of competitors, patients, and regulators. To ensure good medical device training here are some do’s and don’ts that you can follow:
Dos for Medical Device Training Management
For good medical device training management, you must ensure:
⦿ Standardized processes and workflows
⦿ Reduced areas that require reworking
⦿ Repeatable processes and procedures
Don’ts for Medical Device Training Management
For good medical device training management, you must not:
⦿ Avoid showing personnel the defects that can occur due to improper job performance.
⦿ Avoid informing the personnel in charge of verification and validation activities about defects and errors in a medical device.
Conclusion
In conclusion, you must adhere to medical device regulatory standards, especially for training, to ensure quality outcomes and regulatory compliance.
However, ensuring the right medical device training course can be difficult for you. To navigate these complexities, you can collaborate with an experienced medical device regulatory consultant.
These experts can guide you in developing comprehensive training programs, ensuring that all regulatory requirements are met, and helping to document training activities properly.
By leveraging their expertise, you can establish a robust training framework that promotes a competent workforce, mitigates risks, and upholds the highest standards of safety and quality in your medical device manufacturing processes.
