SIFo Medical – Supporting MedTech Companies
This channel is all about Quality-, Risk-, and Supplier Management in the medical device industry. You will receive valuable MedTech knowledge in a concise, easy-to-digest video format.
At SIFo Medical, we are passionate about empowering MedTech companies in Quality- and Supplier Management. From our base in the Austrian Alps, we provide MedTech manufacturers with our expertise in Quality Management, especially with Compliant Technical Documentation, Audits, Test Method Validation, Design Control / Product Development, Packaging Validation, Process Validation, Risk Management, and sourcing components.
Let's connect 💪
PS: We are happy to receive feedback and answer your questions – please write us an e-mail to office@sifo-medical.com
SIFo Medical – Supporting MedTech Companies
Most medical device companies think their supplier documentation is solid.
Most are wrong.
There are 5 very specific gaps that show up again and again under ISO 13485
clause 7.4 — and they're the reason supplier-related findings keep appearing
in audits, even in companies with mature quality systems.
Missing purchasing specifications. Suppliers on the AVL that were never
formally evaluated. Incoming inspection records that can't be traced back
to your requirements. Manufacturing records referencing validations that
were never completed.
In this free 1-hour webinar, Simon Foeger from SIFo Medical walks you
through all 5 non-negotiables:
✅ What each gap looks like in practice
✅ Exactly what auditors check under clause 7.4
✅ A clear, actionable path to close every gap before your next audit
No theory. No fluff. Just the 5 things that determine whether your supplier
documentation passes or fails.
👉 Register here: sifo-medical.com/en/webinar-iso-13485-supplier-aud…
We're looking forward to seeing you on May 20, 2026 at 05:00 PM (CEST)!
2 weeks ago | [YT] | 1
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SIFo Medical – Supporting MedTech Companies
How do you determine the right sample size – without just guessing or blindly following a table?
Most MedTech companies either default to "we've always done it this way" or pick a number from a standard without understanding why. Both approaches create problems in audits.
On April 22nd, we're hosting a free live webinar where we'll walk you through a 6-step approach to risk-based sample size justification – so you can build a statistical rationale that actually holds up when an auditor asks "why this number?"
You'll also get the chance to bring your specific questions to the live Q&A.
🎥 Watch the teaser below.
Save your spot → sifo-medical.com/en/webinar-risk-based-sample-size…
1 month ago | [YT] | 1
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SIFo Medical – Supporting MedTech Companies
Our first long-form interview is live. I sat down with Donald Birnie to talk about the evolution of our industry. From early GMP days to the new QMSR, FDA inspections, risk management, and where AI is taking us next.
This is the conversation I wish I had at the beginning of my career.
Let me know in the comments what stands out to you the most.
Best,
Simon
2 months ago | [YT] | 5
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SIFo Medical – Supporting MedTech Companies
Big news for MedTech professionals: We’re hosting a FREE live online workshop on Test Method Validation (TMV)... and you’re invited.
If TMV still feels confusing or time-consuming, this session is for you.
Here’s what you’ll learn:
- Why TMV is essential for MedTech compliance and product safety
- The most common mistakes (and how to avoid them)
- A clear, practical 5-step approach to validate your test methods correctly
Plus: a live Q&A to ask your specific questions.
Join us and take the guesswork out of validation.
Save your free spot now!
🗓 Date: November 5, 2025
🇩🇪 German Session: 11:00 AM (CET), register here: event.webinarjam.com/8zm5l/register/kkn17u9
🇬🇧 English Session: 5:00 PM (CET), register here: event.webinarjam.com/8zm5l/register/ww2x3iq
Let’s raise the bar for quality and patient safety together.
PS: If you are interested in the recording, please email us at: office@sifo-medical.com
7 months ago (edited) | [YT] | 3
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