Training management in your medical device QMS: what’s required?

Training management is a big deal for medical device developers. Get it wrong, and you risk fines, product recalls, failed certifications, and stalled market access. That’s why your QMS must do more than track training - it needs to help you automate, enforce, and prove compliance. 

Training requirements are explicitly embedded in global quality standards like FDA QMSR, ISO 13485, ISO 9001, and GxP (GMP, GCP, GLP), each mandating robust training processes, record-keeping, and evidence of staff competency.

Before we explore how the right digital tools can support you in securing training compliance, here’s a breakdown of what the different medical device regulations around the world require when it comes to training and competency management.

1. FDA QMSR (Quality Management System Regulation)

Replacing 21 CFR Part 820, the FDA QMSR aligns with ISO 13485 and formalises training requirements for medical device manufacturers selling into the US market.

Personnel competence is not just an expectation - it’s a documented, regulatory requirement.

Key training requirements under QMSR:

• Documented procedures: Manufacturers must establish and maintain procedures to ensure personnel performing work impacting quality are competent.
• Training on current processes: Employees must be trained on the specific tasks they perform, including manufacturing, quality control, and design processes.
• Training updates: Training must be kept current as processes, work instructions, or risk management protocols evolve.
• Objective evidence: Manufacturers must maintain training records to demonstrate that employees were trained before performing work impacting product quality.
• Assessment & competence: The QMSR aligns closely with ISO 13485’s expectation that training effectiveness and employee competence must be evaluated, not merely tracked.

In practice:

When FDA inspectors audit your QMS, they will expect to see training records linked to SOPs and process changes - with evidence that employees were trained and competent before performing work.

2. ISO 13485 – Medical devices

ISO 13485 is the gold standard for medical device quality management systems globally, and is a requirement in the EU, Canada, and many other markets.

Clause 6.2 – Competence, training, and awareness:

• Define required competence: Manufacturers must determine the competence required for personnel performing work affecting product quality—from device design to assembly and final inspection.
• Train for competence: Employees must be trained to acquire and maintain this competence.
• Evaluate Training Effectiveness: Training must be assessed for effectiveness, not simply recorded. This may involve supervisor observations, testing, or practical evaluations.
• Keep records: Records of education, training, skills, and experience must be maintained.
• Ensure Process Awareness: Personnel must be aware of the relevance and importance of their activities and how they contribute to product quality and patient safety.

In practice:

Notified bodies will expect you to provide evidence that your employees are competent for their tasks - with records showing training occurred on the correct SOP version and was evaluated for effectiveness.

3. ISO 9001 – Quality Management Systems

While ISO 9001 is not medical device-specific, it underpins quality systems across various industries.

Clause 7.2 – Competence focuses on ensuring employees are capable of performing their work to achieve product quality objectives.

Key training & competency requirements:

• Define competence: Identify the competencies required for each role impacting product quality.
• Provide training: Take action (training, mentoring, or other development) to fill gaps.
• Evaluate the impact: Assess whether training and development actions improved competence.
• Maintain records: Keep objective evidence of competence and training completion.

Companies certified to ISO 9001 must demonstrate they have trained and competent staff - especially when providing critical components or assemblies for medical devices.

4. GxP – Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)

GxP regulations cover the entire life cycle of a medical device—from design and development to clinical trials and manufacturing.

The focus is on ensuring data integrity, patient safety, and product quality—and staff competence is fundamental to this.

Key GxP training requirements:

GMP (Good Manufacturing Practice):

• Personnel must be trained in manufacturing processes, hygiene, and contamination controls.
• Ongoing training is required to maintain competence.
• Training effectiveness must be assessed.
• Records must be available for audits.

GCP (Good Clinical Practice):

• Clinical staff must be trained in trial protocols, data handling, and patient safety procedures.
• Investigators must be trained in regulatory requirements.
• Training records must demonstrate protocol adherence during clinical trials.

• Lab personnel must be trained in test methods and data recording procedures.
• Competence evaluations are critical for personnel conducting safety and biocompatibility testing.
• Training records must be audit-ready.

In practice:

GxP inspections focus heavily on staff competence - any gaps in training documentation or competence validation can lead to regulatory action or trial failures.

The challenge: scaling training management for medtech start-ups and scale-ups

When medical device companies are small, training compliance is often managed manually using a combination of email, spreadsheets or file-sharing apps. At this scale, training records can be scattered across HR systems and cloud storage, but:

• Spreadsheets can be easily maintained to track who’s read what
• Document updates can be more easily communicated by email
• Sign-off can be achieved with third party apps like DocuSign

This may all feel manageable in the early days of a start up, but it can quickly collapse as your business begins to grow.

Why DIY QMS systems can fail as you scale

1. Tracking training progress can become chaotic

As your team grows from 10 to 50 and beyond, manual tracking of training can quickly spiral into confusion. Without the right digital tools, you may have no automatic record of:

• Who has completed training on the latest sterilisation procedure?
• Which operators are overdue on refresher training?
• Have design engineers been briefed on the new biocompatibility risk evaluation process?

Chasing these answers across spreadsheets and shared drives becomes a full-time job, distracting your quality team from higher-value work.

2. Process and document changes outpace your training record-keeping

In early-stage development, processes and SOPs change frequently:

• Detected non-conformances can necessitate quick change of SOPs
• Risk management updates require new controls.
• Test procedures evolve as devices move through verification.

If your system is not capable of triggering re-training as SOPs change, employees may continue following outdated processes, unaware of critical updates.

3. Audit preparation becomes harder

When regulators like the FDA or notified bodies request training records, they expect instant access to clear, validated evidence of:

• Who was trained?
• On which SOP version?
• When?
• How was competence validated?

Manually cross-referencing training records with document versions becomes a last-minute scramble, increasing the risk of errors and findings.

How a dedicated eQMS can help

Without a centralised system, tracking and retrieving training records quickly becomes overwhelming - especially under the pressure of an audit. A missing record or outdated SOP link can raise red flags, leading to non-conformities, certification delays, or even regulatory action. To avoid these risks, medical device companies need an eQMS that ensures training compliance is built into daily operations.

Managing training requirements through an eQMS

The sooner you can establish a digital process for automating and controlling your teams training needs, the easier it will be to:

• Onboard new team members
• Scale your training regimes
• Maintain consistency in your quality approach
• Prepare for quality audits

To meet FDA QMSR, ISO 13485, ISO 9001, and GxP training requirements, look for a digital Quality Management System that can help you:

1. Define training requirements

• Set training needs by role, task, or process.
• Specify required materials (SOPs, work instructions, videos, external certifications).
• Define assessment methods (quizzes, practical evaluations, supervisor validation).
• Set proof of competence requirements (e.g., certificates, evidence uploads).
• Establish deadlines and recurring refresher cycles.
• Apply version control to training requirements.

2. Assign training requirements and trigger training sequence

• Automate training assignments based on roles or document updates.
• Link training to document versions to ensure staff are trained on the correct SOPs.
• Support individual training timelines for new starters.
• Create role and skill-based training paths.
• Record external training (e.g., third-party certifications).

3. Support competency validation & assessment

• Require multi-step training (e.g., read document → quiz → supervisor sign-off).
• Support quizzes, practical assessments, and evidence uploads.
• Track pass/fail outcomes and record retraining if needed.

4. Support real-time progress tracking

• Track training status: Assigned, In Progress, Overdue, Completed, Expired.
• Set deadline alerts for employees and managers.
• Monitor team-level progress.

5. Training record-keeping & version control

• Maintain individual training records linked to document versions.
• Store proof of competence (e.g., certificates, assessment results).
• Ensure FDA Part 11 compliance (electronic signatures, timestamps, audit trails).
• Retain training history even for leavers—never delete records.

6. Reporting & audit readiness

• Individual and team training reports (status, gaps, overdue training).
• Competency matrix to identify skills gaps.
• Version impact analysis to identify retraining needs after SOP updates.
• Exportable audit-ready reports showing document version links.

7. Retraining & refresher management

• Automate refresher training cycles.
• Track training expiry dates.
• Auto-assign re-training when documents or procedures change.

Conclusion

To comply with FDA, ISO 13485, and GxP standards in a stress-free way your learning management process should be digitised and automated. By choosing the right digital tools you can move beyond a simple box-ticking approach to embed a fully auditable training regime that streamlines onboarding, requirements planning and quality compliance.