Free Live Webinar for QA/RA Leaders

The 5 Non-Negotiables to Pass Your Next ISO 13485 Supplier Audit

What auditors actually look for in supplier documentation — and how to be ready before they ask.

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Audit-Proof Supplier Documentation

Learn the 5 documentation areas every ISO 13485 auditor probes – from purchasing specs to DMR/DHR. Build supplier files that hold up under scrutiny instead of triggering major NCs.

One Framework, Both Sides of the Audit

Apply the same 5 Non-Negotiables whether you're a MedTech manufacturer controlling suppliers, or a supplier qualifying for MedTech contracts – instead of running two separate playbooks.

More Confidence in Audits

Understand exactly what auditors want to see – so audit conversations become predictable, focused, and fact-based.

Why This Webinar Matters for MedTech Leaders

Missing Supplier Documentation Costs More Than the Fix

Stop reacting to findings. Close the gaps before the audit.

A single major NC in supplier management triggers re-audits, certification delays, and lost contracts. The right documentation framework prevents the finding and the months of corrective action behind it.

Auditors Don't Just Check – They Read
"We have it" isn't the same as "it holds up."

ISO 13485 auditors check the change-control clause inside your QSA, the date of your last supplier re-evaluation, the validation behind every test method in your DHR. That's where findings live – not on the cover page.

Audit-Ready Files Win
Focus effort where audits are decided.

The 5 Non-Negotiables are where every ISO 13485 audit is won. Build files around these areas, walk into clean reports.

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Learn about the 5 Non-Negotiables in MedTech Supplier Documentation and pass your next ISO 13485 with ease. 

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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 supplier audits, supplier development, and component sourcing for medical device manufacturers – across global supply chains and on both sides of the audit table.

 

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 inside real supplier files.

 

In this webinar, Simon brings his field experience directly to supplier documentation under ISO 13485 — showing exactly what auditors probe, where the structural gaps hide, and how to close them before they become major NCs. Whether you control your suppliers or want to stay qualified as one, this is the framework he applies in client engagements every week.

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

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

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

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

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

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 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 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 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

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

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

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

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

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

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 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 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 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

Who This Webinar Is For

MedTech Decision Makers

CEOs, founders, and QM heads at medical device manufacturers  who ultimately own the audit outcome and the supplier strategy that drives it.

QA/RA & Procurement

QA/RA leaders, regulatory specialists, and purchasing teams running supplier qualification, Quality Agreements, and audit prep on the manufacturer side.

MedTech Suppliers

Companies preparing to qualify – or stay qualified – as a source for MedTech manufacturers, including those facing a customer audit or pursuing their own ISO 13485 certification.

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Supplier Documentation

with Simon Foeger | MedTech Expert

Stop Relying on Certificates – Learn the 5 Non-Negotiables Every Auditor Actually Probes 

In this webinar, you'll learn the 5 Non-Negotiables that decide every ISO 13485 audit – and how to satisfy them without dragging your team onto the audit-prep treadmill.

 

Close the gaps. Pass the audit. Stay qualified.

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