Quality Management
Are you struggling to implement MDR, FDA QSR, or ISO 13485 requirements in a practical way? We translate complex regulations into efficient processes that withstand audits and are built for long-term success.
Your MedTech Partner for Quality- and Supplier Management.
Accelerate your medical device development with hands-on support in design control, validations, and risk management. Optimize your supply chain with smart sourcing and sharpen your skills through actionable online training.
Why Work With SIFo Medical
Here are four reasons why our clients trust us and why we might be an excellent fit for you too:
With 12+ years in medical device engineering, Simon has successfully led product development, supplier qualification, and compliance projects worldwide – from setting up MedTech manufacturing sites in China to training professionals at TÜV SÜD. Simon is committed to practical, results-driven solutions.
Sophia brings a strong background in key account management and international business to SIFo Medical. She ensures smooth operations, leads strategic marketing initiatives, and helps drive company growth.
MedTech Blog
Do you want to stay ahead in MedTech quality and supplier management? Our blog delivers actionable insights and best-practices on test method validation, process validation, risk management, and more.
Success Stories.
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You can contact us via e-mail: office@sifo-medical.com, fill out the contact form on our website, or directly book your initial consultation with Simon.
Simon Föger founded SIFo GmbH in 2020 with the vision to create a network of quality experts to support as many medical device companies as possible to successfully navigate the complex world of MedTech – for better patient outcomes.
SIFo Medical is located in Telfs, Tyrol, Austria.
SIFo Medical supports you in bringing your Quality Management System to peak performance. We ensure your processes are efficient while considering the safety and compliance with MedTech regulations and standards.
We are specialized in the following areas:
- Test Method Validation
- Process Validation
- Packaging Validation
- Design Control / Product Development
- Supplier Audits
- Supplier Development
- Sourcing compliant components
- Risk Management
- Technical Documentation (MDR 2017/745, FDA, ISO 13485)
We tailor our services to your needs – from expert consulting and hands-on implementation to reliable component sourcing and impactful training programs, available both online and offline.
SIFo Medical partners with medical device companies of all sizes – from innovative startups to established SMEs and large-scale enterprises – providing expert support in the following areas:
- Compliant Technical Documentation (acc. to MDR 2017/745, FDA & latest MedTech standards)
- Design Control / Product Development
- Test Method Validation (TMV)
- Packaging Validation
- Process Validation
- Risk Management
- Supplier Quality Audits
- Component sourcing
Subscribe to our newsletter and follow us on LinkedIn:
SIFo Medical: https://www.linkedin.com/company/sifo-gmbh
Simon Föger: https://www.linkedin.com/in/simonfoeger/
Subscribe to our YouTube channel for practical insights on MedTech quality, risk, and supplier management and stay ahead with informative, practical videos:
https://www.youtube.com/@SIFoMedical
Contact us
Book an appointment
Arrange your initial call with our CEO Simon Foeger
to discuss your project and clarify all your questions.
©2025 by SIFo GmbH
Bärenweg 11, 6410 Telfs, Austria
office@sifo-medical.com