Online Training in Test Method Validation (TMV) for Medical Devices

TMV Training – Become an Expert in Test Method Validation

Learn how to validate your test methods with confidence.

This training takes you from the regulatory foundations to practical study design, data evaluation, documentation, and life-cycle management – everything you need to ensure reliable and compliant test results.

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Gain Clarity in a Complex Regulatory Landscape

Test Method Validation can feel like a maze of ISO references, statistics, and unclear expectations. This training breaks it down – with logic, structure, and practical examples. Learn what regulators expect and how to implement it efficiently.

Learn from Years of Experience – Distilled into Proven Strategies

Led by a MedTech expert and TÜV SÜD Academy trainer who has supported hundreds of manufacturers and suppliers worldwide, you'll learn exactly what works in practice. Avoid common pitfalls, and apply proven strategies to make your TMV audit-ready.

Save Time and Validate with Confidence

Stop reinventing the wheel. Learn from best practices that you can apply immediately in your own projects. With this system, you’ll move from uncertainty to confidence – knowing your test methods are solid, compliant, and defensible in any audit.

Your Online Training in Test Method Validation (TMV) for Medical Devices

TMV Training

Online Training in Test Method Validation (TMV) for Medical Devices

Gain full confidence in your TMV process – develop audit-ready, compliant test methods that meet EU and FDA expectations.

2 hrs. 25 min. | 6 chapters

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Why Test Method Validation Training Matters in MedTech

For medical device manufacturers, the journey from concept to market approval is long, complex, and heavily regulated. The one principle that governs every step is safety. A device must not only function as intended, it must do so reliably, every time.

Testing is the cornerstone of ensuring product safety. Yet here lies a widespread misunderstanding: testing alone is not enough. Many manufacturers and suppliers invest heavily in testing, but often fail to validate their test methods. Without validation, even the most sophisticated tests can generate misleading results.

The consequence? Faulty products in the field, batch rejections, wasted resources, and in the worst cases: costly recalls and reputational damage.

This is why training in Test Method Validation (TMV) is so crucial. It provides the knowledge and framework to select the right test methods, validate them systematically, and demonstrate compliance to regulators, notified bodies, and customers.

“A Test Method without validation is like driving a car without a speedometer – you might be driving fast, but you are not in control.”

– Simon Foeger

Your Test Method Validation Trainer: Simon Foeger

Simon Foeger is a recognized expert in medical device quality and validation, trusted by leading organizations across Europe. As a trainer at TÜV SÜD Academy, he has educated countless professionals in Test Method Validation (TMV), process validation, and statistics in MedTech.

With years of hands-on experience in the medical device industry, Simon combines deep regulatory knowledge with a pragmatic approach. He knows the realities manufacturers face (tight timelines, strict auditors, and complex requirements) and translates them into clear, practical solutions.

What makes Simon stand out as a trainer is his ability to make complex topics simple. Participants consistently value his structured explanations and relatable examples. Instead of overwhelming theory, Simon ensures that every concept is connected to the daily challenges of medical device development and compliance.

Whether you are new to TMV or seeking to sharpen your expertise, Simon provides the insights and confidence you need to validate test methods effectively, and to demonstrate compliance with regulators, notified bodies, and customers.

Your Roadmap to Become an Expert in Test Method Validation

The Test Method Validation (TMV) Training is divided into six structured modules, each building on the previous one. For every module, you'll get detailed presentation slides and a video tutorial – giving you the flexibility to learn at your own pace and revisit key topics anytime to deepen your understanding.

01 | Introduction & Fundamentals

Understand regulatory drivers & hierarchy.
Differentiate test types and data categories.
Define essential validation prerequisites.

02 | Planning the Validation

Identify triggers for validation or revalidation.
Develop a complete test method validation plan.
Define parameters and acceptance criteria clearly.

03 | The Study in Detail

Explain accuracy, precision, trueness, bias.
Design studies for variable/attribute methods.
Analyze variation and Gauge R&R results.

04 | Documentation, Data Analysis & Reporting

Know how to collect data.
Implement blinding to reduce operator bias.
Analyze and interpret TMV data accurately.

05 | Life Cycle Management

Understand complete test method life cycle phases.
Implement monitoring to maintain method validity.
Manage changes with risk-based revalidation.

06 | Summary & Practical Tips

Consolidate key concepts from all modules.
Apply validation principles to real scenarios.
Identify next steps for continuous improvement.

What Clients Say About Working With Us

We had a training on process validation and test method validation at our company. SIFo addressed the topics perfectly and used our own case examples to explain certain aspects in more detail.

Jerome Bachmann

Head of Quality Assurance

Simon is an honest, motivated, and efficient personality. We had the opportunity to work together over short phases, where Simon was very self-sufficient and approached issues proactively. With his expertise, he was able to handle tasks very quickly on his own. Due to his open nature, the collabo...

Markus Hügel

Head of Project Engineering

The collaboration with SIFo Medical was excellent in every respect. We particularly appreciated the transparent and timely communication as well as the clear and comprehensible explanations. Thanks to their support, we were able to establish a connection between risk management and validation and...

Pierre Koenen

Quality Manager

Our notified body required proof of a test method validation for the tests assessing seal seam quality in accordance with ISO 11607-1. The TMV Guide from SIFo Medical was an outstanding support throughout this process. The video guides were especially valuable – clear, practical, and perfectly ...

Roman Becking

Validation Engineering Manager

We carry out audits worldwide with Resyca, some of them with very specific industry sectors. We are therefore also dependent on external auditors. We came to SIFo Medical via a recommendation. The communication went smoothly right from the start. With the support of Mr. Foeger, we were able to ca...

Dr. Raimund Gleixner

Head of Quality & Regulatory Affairs

I worked with Simon for about 3 years in an interdisciplinary team on an international project. With Simon's support, we successfully overcame both intercultural and time-critical challenges. Simon is an all-rounder. He quickly familiarizes himself with complex topics and knows how to pick u...

Anna Spehl

Head of Production Engineering

With Simon, we have a top consultant at our side at Dr.Ausbüttel. Together, we have developed and performed test method validations that provide a firm basis for our quality work in MDD and MDR audits. SIFo Medical's great strength is its network. No question goes unanswered. Simon is a fri...

Axel Brauckmann

Head of Quality Assurance

At SIFo, you have a direct contact person with interdisciplinary competencies who combines technical, qualitative, and business know-how. We have significantly benefited from the direct communication channels SIFo maintains with its suppliers. We received several proposals for possible solutions ...

Louis Andres

Head of Purchasing

Simon was very instrumental in supporting our cross-function team during the assessment and the definition of an appropriate and compliant approach to process validation. With an hands-on approach and thanks to his concrete expertise and experience he first quickly got the actual picture to under...

Riccardo Pellegrini

Global Head QM/RA

I was working with Simon for one year on a PCBA testing concept. His role was to qualify and validate a Flying Probe machine and other testing machines. His way of tackling and solve problems was a key attribute to the success of the project. Every time I passed on an activity, I was very confide...

Sergej Sobolewski

Project Manager

SIFo Medical was like opening Pandora’s box for us – in the best way. We realized that while we had already been doing many things right, SIFo Medical helped us see where we could grow and further improve the processes we had established.