Free Webinar for QA/RA Leaders

 

Still Confident Your TMV Will Survive the Next Audit?

The 7 Mistakes That Trigger FDA Warning Letters

+ How to Fix Them Before Inspectors Find Them

60 minutes. 7 critical gaps. A clear action plan you can start today, without rebuilding your validation system from scratch. 

Watch Free Webinar

Trusted by MedTech Companies

"With SIFo Medical, we completed our test method validation in a quarter of the usual time."

– Roman Becking, Validation Engineering Manager, pfm medical mepro GmbH

Avoid Audit Findings

Learn which compliance gaps MedTech companies so often oversee and avoid costly audit findings with simple, yet clear actions.

Eliminate Blind Spots

Identify the most dangerous TMV errors MedTech companies repeatedly make and learn how to eliminate them with clear, regulator-accepted validation principles.

Take the Lead

Stop reacting to findings – start preventing them: set the right priorities by learning from others’ mistakes and gain clarity on what truly matters.

These 7 TMV Gaps May Be in Your System Right Now

Test Method Validation is one of the most frequently cited areas in FDA warning letters.

The same 7 mistakes keep showing up, year after year, across companies of every size.

 

Internal reviews often miss them – not because teams aren't diligent, but because these gaps hide in plain sight.

 

But auditors? They know exactly where to look.

 

This webinar shows you exactly which 7 mistakes to look for, why they keep happening, and how to fix them – with clear, practical steps you can act on immediately.

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In 60 Minutes, You'll Have:

A Clear TMV Failure Map

Know exactly which 7 TMV gaps auditors target first – so you can check your own system before they do.

Regulator-Accepted Validation Principles
  

Stop guessing what auditors want. Get the validation principles that FDA and Notified Bodies actually accept – based on real inspection outcomes, not textbook theory.

A Priority Action List

Walk away with a clear "fix this first" list you can start acting today – without needing to overhaul your entire QMS.

Confidence for Your Next Audit

Replace the anxiety of "will we pass?" with the clarity of knowing exactly where you stand and what to do next.

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Your Host: Simon Foeger

 

 

MedTech Auditor | TMV Specialist | Founder of SIFo Medical

Simon has spent over a decade inside the quality systems of medical device companies – from startups to global manufacturers across Europe, America, and Asia.

 

As a TUV SUD Academy trainer, he's trained hundreds of professionals on TMV compliance.

 

As a consultant, he's helped companies resolve FDA Warning Letters and pass audits they weren't prepared for.

 

In this webinar, he shares the patterns he sees repeated across the industry – the 7 mistakes that keep showing up, and the practical fixes that actually work.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

This webinar is for you if...

Decision Makers

If you're a CEO or founder and you need to understand TMV risks without wading through 200 pages of guidance documents.

QA/RA Professionals

If you're a QA/RA leader and you're not 100% sure your TMV documentation would hold up under FDA scrutiny.

Engineers

If you're an engineer whose design decisions depend on test results and you want to know those results are actually validated.

Free Webinar with Simon Foeger

The 7 Deadly Sins of TMV

60 minutes. 7 critical gaps. A clear action plan you can start today.
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