Medical Device Regulatory and QMS Training – Practical, Interactive, Impactful
Learn the "Why", Not Just the "What"
Our medical device training programs go beyond theory. We help your team understand not only what is required by ISO 13485, MDR, IVDR, ISO 14971, IEC 62304, and other related standards, but also why these requirements exist and how they can be applied within your organization.
“Compliance starts with understanding, but mastery begins with purpose.”
From Regulation to Real-World Implementation
Our training combines regulatory knowledge, practical examples, and interactive workshops that connect the dots between regulations, quality management, and product lifecycle activities.
You won’t just memorize clauses, you’ll understand their intent and learn how to implement them effectively for the benefit of your organization.
We Guide You Through Three Phases of Learning.
1. Understanding the "WHAT" — The Regulations and Standards
We start by mapping the regulatory landscape and identifying what each standard or regulation requires:
- Which processes and organizational areas are affected
- Who is typically responsible for each activity
- How individual standards fit together (ISO 13485, MDR, IEC 62304, ISO 14971, etc.)
- Where in the medical device lifecycle, each requirement or standard becomes critical
2. Interpreting the "WHY" — The Meaning Behind the Words
We then translate complex legal or normative language into actionable insights:
- Understand the intent behind each regulatory clause
- Learn how standards connect to real-world challenges
- See why certain requirements exist — from risk reduction to patient safety
3. Applying the "HOW" — Turning Knowledge into Action
Finally, we explore implementation scenarios and practical examples:
- Real-life case studies from daily operations, product development, and maintenance
- Examples of best practices in documentation, process validation, or risk management
- Interactive group discussions on how to apply standards in your own company
“Knowing the rule is knowledge. Applying it with confidence is a skill.”
EU MDR 2017/745 Training - From Regulation to Real-World Application
See the Regulation Through the Lens of Your Business
Our EU MDR 2017/745 training is not a page-by-page walk-through of the regulation.
We go beyond articles and annexes to help you understand how MDR truly impacts your organization, from product design and quality management to post-market surveillance and business strategy.
“EU MDR - understand what it means for you.”
What You Will Learn in This Training
Through structured sessions and real examples, you will learn:
- How to interpret MDR requirements from a strategic and operational perspective
- The interfaces between MDR and your Quality Management System (QMS)
- What to expect during audits and interactions with Notified Bodies
- How MDR shapes the creation of Technical Documentation
- How MDR influences product updates, incident handling, and market continuity
“Understanding MDR isn’t about memorizing clauses, it’s about seeing how every clause shapes your business decisions.”
Bringing Regulation and Execution Together
EU MDR affects every department and every phase of your product lifecycle.
Understanding its implications helps you:
- Avoid costly project delays
- Plan realistic development and certification timelines
- Optimize collaboration between engineering, regulatory, and management teams
- Strengthen your organization’s readiness for audits and certifications
Quality Management System Training – ISO 13485 and 21 CFR 820 in Practice
From Compliance to Operational Excellence
Our Quality Management System (QMS) training is built on a simple belief: compliance is not the goal; it’s the result of well-structured, efficient processes that work the best for your organization.
We go beyond teaching what ISO 13485 or 21 CFR 820 requires. We put more effort into explaining to you how these standards might work for your organization.
Learning by Doing, Not by Reading
You won’t find us reading the standard line by line. Instead, we translate the requirements into practical implementation guidance, showing how each element connects to real-world operations.
We discuss:
- How to implement specific requirements in a way that adds real value to your organization
- Which parts of the standards are critical for your type of business, and which can be streamlined or even skipped
- How proper QMS design supports scalability, maintainability, and decision-making
Risk-Based Approach – Focus Where It Truly Matters
Our training strongly emphasizes a risk-based approach because not all chapters of ISO 13485 or 21 CFR 820 have the same importance for your business.
Some requirements might look negligible in the standard, but they have a high impact on your efficiency and daily operation, while others receive too much attention in many QM systems without providing any real operational benefit for you.
We show you:
- How to identify which processes deserve more attention based on your product type and organization size
- How to use risk-based thinking to prioritize QMS improvements
- How to make your system leaner and smarter without losing compliance integrity
“Not every clause has equal weight — smart compliance starts with knowing where to look deeper.”
Every example comes from our experience in building, auditing, and transforming QMS implementations across medical device companies of all sizes, and you’ll take this experience with you after this training.
“Compliance becomes effortless when your QM system makes sense.”
IEC 62304 and 21 CFR 820.30 Design Controls Training
Compliance That Makes Sense for Developers
Our IEC 62304 and 21 CFR 820.30 Design Controls training bridges the gap between regulatory requirements and real-world software development. We approach design controls not only as consultants, but also as developers who have built and released medical device software under both FDA and EU regulatory frameworks.
“Confidence in compliance built on practical experience.”
Design Controls Training for Software Reality
We’ve designed and implemented complete design control procedures for organizations of all sizes, from small startups to global medical device corporations.
That’s why our training reflects the reality of software teams, agile environments, CI/CD pipelines, modern toolchains, and translates these into compliant, traceable, and auditable systems aligned with IEC 62304 and 21 CFR 820.30.
You’ll learn how to:
- Build a development process that is both compliant and efficient
- Apply design control principles without paralyzing innovation
- Understand how software lifecycle processes fit into the overall quality management system (QMS)
- Avoid overengineering your documentation while still being fully audit-ready
“True compliance isn’t about the amount of documents, it’s about making the right ones meaningful.”
Where Regulations Meet Practical Implementation
Our training is designed to connect what teams already do — planning, coding, testing, and verification — with what the standards require. Most development teams already operate in a way that supports quality; our role will be to help you align existing practices with regulatory expectations, rather than reinventing your process.
We will teach you how to:
- Structure design controls from User needs and System requirements down to Software detailed design
- Map agile practices to design control requirements
- Integrate verification activities into the CI/CD process
- Maintain traceability between requirements, cybersecurity and safety risks, and tests
- Implement architectural design
- Document and maintain SOUPs/OTS
- Create development documentation that serves both engineers and auditors
“Let’s shape standards around how your team already works.”
A Holistic Approach to Design Controls and Software Lifecycle
Our medical device software training goes beyond a IEC 6230 standard. We deliver a comprehensive, interconnected view that answers all the key questions appearing in medical device software development — from risk management and cybersecurity to validation and agile practices.We demonstrate how IEC 62304 overlaps with 21 CFR 820.30, illustrating how these regulations can be combined into a single, functioning unit.
We enrich this training with insights from:
- IEC 12207 and IEC 15288 – connecting the system and software engineering
- IEC 82304 – product-level validation and safety of health software
- IEC 81001-5-1 – embedding cybersecurity into the full product lifecycle
- ISO 14971 / ISO 24971 – connecting software activities with risk management principles
- AAMI TIR32:2004 – practical methods for medical device software risk management
- AAMI TIR57:2016 – best practices for medical device security
- AAMI TIR45:2023 – agile development principles aligned with regulatory expectations
After this training, you’ll understand what lies behind software development standards, why they require certain activities, whether the requirements already connect to your current development practices, and how applying them can strengthen both your team’s work and your organization’s outcomes.
ISO 14971 & ISO TR 24971 Training
Turning Risk Management into Practical Understanding
Our ISO 14971 and ISO TR 24971 training is grounded in hands-on experience. We have designed and implemented risk management systems for a diverse range of organizations, including cloud-based medical software products, hybrid hardware-software solutions, pharmaceutical companies developing drug administration systems, and medical startups creating mobile companion apps.
We’ve led transformation projects, streamlined risk procedures, and built risk frameworks that actually work in day-to-day operations.
With our medical expertise, we bridge the gap between technical development and clinical reality, helping you focus on risks that can actually occur, rather than theoretical scenarios that are difficult to quantify or control.
From Concepts to Effective Risk Reduction
We begin the training by revisiting the core principles of risk management, always through practical examples.
You’ll gain a solid understanding of:
- Hazards, hazardous situations, and risks in real contexts
- Risk analysis, risk evaluation, and risk control based on actual case studies
- The meaning and intent behind each concept, not just the definitions
This foundation enables participants to:
- Independently navigate and interpret risk-related standards
- Build or refine risk management procedures where necessary
- Communicate confidently with regulators and auditors
“Knowing the terms is knowledge, understanding their purpose is mastery.”
Connecting Risk Management with the Bigger Picture
Risk management doesn’t exist in isolation. In the risk management training, we will show you how to integrate it with the rest of your medical device lifecycle activities and regulatory frameworks.
You’ll learn how to:
- Link risk management with requirements engineering to define and trace risk control measures
- Connect cybersecurity with product safety, identifying overlaps and shared controls
- Understand how ISO 14971 aligns with IEC 62304, and how the software safety class is impacted
- See how risk management directly affects medical device classification or clinical evaluation
You will not just apply risk management, you will understand how it drives smarter development decisions across your entire organization.
Customized QMS Training That Fits Your Organization
Every organization is different, and so are its training needs. That’s why we don’t deliver pre-packaged training modules. Instead, we adapt every session to your company’s goals, priorities, and maturity level.
Our training topics and examples are tailored to your context. Some organizations want to combine QMS and software development training; others need to clarify regulatory strategy, strengthen the understanding of the CAPA system, or improve supplier management and data analysis.
We also provide focused sessions on audits, management reviews, or cybersecurity integration into the software lifecycle.
For smaller or early-stage companies, we can offer combined training that covers ISO 13485, IEC 62304, ISO 14971, and the EU MDR, helping you understand how these regulations interrelate.
We design each session as an interactive workshop, not a one-way presentation. These trainings are most effective when held for teams of your company, not individuals, encouraging shared understanding and collaboration.
Before every session, we discuss your needs, focus areas, and team composition, and then shape a program that truly fits your organization.
“The best training doesn’t follow a template — it follows your challenges.”
Training Structure and Duration
Our training sessions are designed to be flexible and scalable:
- Focused trainings (4 hours): Ideal for specific topics such as CAPA, supplier management, or audit preparation.
- Full-day workshops (8 hours): Designed as interactive sessions where we cover a complete standard, analyze real use cases from your organization, and work on practical solutions.
- Extended training series (4–8 sessions over several weeks):Recommended for participants deeply involved in QMS and regulatory processes, such as:
- Quality Management Representatives
- Regulatory Affairs Specialists
- QA Managers
- Risk Managers
- Cybersecurity Managers
- Design Control Leads.
Most sessions are designed for 5–10 participants, ensuring engagement, discussion, and direct feedback.
Training Language and Delivery Options
All our trainings are available in English or German, including complete training materials prepared in the selected language.
We offer both online and on-site formats, depending on what best fits your team’s needs and schedule.
Our online trainings are available to clients worldwide and are ideal for distributed teams or organizations with participants joining from multiple locations.
Our on-site workshops are conducted directly at your premises, bringing real collaboration and hands-on interaction to your team environment.
We regularly deliver in-person sessions across Germany, Switzerland, Austria, Denmark, Sweden, the Netherlands, and Italy. However, we can also arrange on-site training in almost any part of Europe.