Free Webinar

 

Risk-Based Sample Sizes in MedTech

6 Steps to Statistically Sound and Cost-Efficient Justification

February 18, 2026 | Live Webinar + Q&A

Learn how to justify sample sizes using a clear, risk-based and statistically sound approach that reduces validation effort and cost. Gain a practical framework you can confidently defend in audits across TMV, design verification, packaging, and process validation.

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Defensible Sample Size Decisions

Learn how to justify sample sizes using a structured, risk-based logic that auditors and notified bodies actually accept – while avoiding unnecessary cost and effort.

One Framework, Multiple Use Cases

Apply the same 6-step approach across test method validation, packaging validation, design verification, and process validation – instead of reinventing the logic every time.

More Confidence in Audits and Reviews

Understand how to clearly explain and document your sample size rationale so discussions with auditors become predictable, focused, and fact-based.

Why This Webinar Matters for MedTech Leaders

Unclear Sample Sizes Cost Time and Money

Stop wasting resources. Close compliance gaps.

Poorly justified sample sizes lead to overtesting, rework, and delayed approvals. The right rationale reduces effort without increasing risk.

Auditors Expect Justification, Not Habits
Sample sizes must be justified.

Regulators look for clear, risk-based reasoning behind your sample sizes. "We've always done it this way" is no longer acceptable.

Risk-Based Decisions Win
Focus effort where it matters most.

Risk-based sample sizes focus resources where patient and product risk are highest. This improves compliance while keeping validation efficient.

Join our Free Webinar

Learn how our 6-step approach helps you determine the right sample size for your specific use case – saving time, effort, and cost.

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About the Speaker: Simon Foeger

Simon Föger is a MedTech expert and auditor with over a decade of hands-on experience in design control, verification, validation, and risk management.

 

As a TÜV SÜD Academy trainer, he trains professionals worldwide in test method validation (TMV), applied statistics, and process validation, with a strong focus on making regulatory requirements practical, defensible, and audit-ready.

 

In this webinar, Simon brings his field experience directly to the topic of risk-based sample sizes – showing how to move away from arbitrary numbers and toward clear, statistically sound justifications that reduce validation effort, control cost, and stand up confidently in audits.

 

Simon is also the founder of SIFo Medical, where he and his team develop expert guides, online trainings, and AI-powered tools to support faster, smarter compliance in the medical device industry.

Clients Who Trust in SIFo Medical

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

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

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

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.

Robert Hernández Pérez

Senior Quality Engineer

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

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

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

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

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

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

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

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

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

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

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.

Robert Hernández Pérez

Senior Quality Engineer

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

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

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

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

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

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

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

Who This Webinar Is For

Decision Makers

MedTech CEOs and founders who want clarity on risk-based approaches and priorities before audit findings dictate their roadmap.

QA/RA Professionals

QA/RA leaders responsible for audit readiness, compliance decisions, and defending their projects during inspections.

Engineers

R&D and engineering leads working on medical device verification and validation topics. 

Join our Free Webinar

Risk-Based Sample Sizes

with Simon Foeger | MedTech Expert
Stop Guessing Your Sample Sizes – Learn the Risk-Based Approach Auditors Actually Want to See

In this webinar, you’ll learn a practical 6-step framework for justifying sample sizes that satisfy regulators while keeping costs reasonable.
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No advanced statistics required – just bring your willingness to challenge "we've always done it this way."

 

Get audit-ready. Gain clarity. Take the lead.

 

Secure your seat now!

Register for Free

Register for Free