Expertise / About

Your MedTech Expert for Efficient Solutions

From our base in the Austrian Alps, we support MedTech companies worldwide with practical, regulatory-compliant solutions.

Whether it’s hands-on support with validation, supplier audits, component sourcing, or supplier development – our goal is to deliver efficient, tailored results that fit your specific needs and accelerate your success.

Our Expertise

At SIFo Medical, we combine deep technical expertise with a pragmatic, hands-on approach to provide tailored solutions.

Whether you're a startup or an established manufacturer, we help you implement sustainable improvements and stay ahead in a highly regulated environment.

You can count on us as a reliable partner for compliance, efficiency, and innovation.

Quality Management

Our expertise lies in critical areas of quality management that really move the needle – design control, test method validation, packaging validation, process validation, and risk management.
We know the regulations, but more importantly, we know how to make them work in day-to-day operations. Our goal is to help you build systems that are not only compliant but also efficient and scalable.

Supplier Management

Your supply chain plays a huge role in product quality. We support you with audits, supplier development, and sourcing strategies that reduce risk and improve performance. Whether you're just setting up your supplier base or managing complex international relationships, we tailor our approach to your needs with practical solutions that work.

MedTech Trainings

Our founder, Simon, is a certified trainer for TÜV SÜD Academy, where he teaches test method validation, process validation, and statistics specifically for MedTech professionals. At SIFo Medical, we offer in-house sessions, online training, and practical tools, such as our TMV Guide, so your team can learn precisely what they need, when they need it.

International Experience

From Austria to Mexico, China, Hong Kong, Taiwan, or Vietnam – we have gathered extensive international experience, learned about cultural differences, and how to successfully manage international clients and suppliers. We use this knowledge to your advantage.

What sets SIFo Medical apart?

Deep MedTech Know-How

Benefit from deep technical expertise trusted by leading industry training institutes. We share first-hand knowledge – the same insights used to train professional auditors. More than just consulting, we actively support you on your path to success by implementing efficient solutions that drive results.

Superior Support Quality

Every concern receives full attention. Our team takes ownership, communicates openly, and handles each project with care and precision. Patient safety stays at the center of every decision, and the goal remains clear: deliver results that exceed expectations – confidentially, reliably, and with purpose.

Personalized and Hands-On

Direct communication moves projects forward – faster, clearer, and with fewer detours. Expect open dialogue, swift decisions, and solutions tailored to your specific goals. Every detail aligns with your needs because tailored support delivers better outcomes.

Future-Ready Solutions

We believe: forward-thinking is essential. The MedTech industry is on the brink of a major transformation, with AI poised to simplify many aspects of daily work. We're actively contributing to this shift by developing efficient AI solutions that are both compliant and tailored to the specific needs of the MedTech industry.

Meet the Team Behind SIFo Medical

Simon Föger

CEO & Founder of SIFo Medical

With over 12 years of hands-on experience in the medical device industry, Simon personally leads all customer projects at SIFo Medical.

His background includes global product development, supplier qualification, and regulatory compliance – from establishing manufacturing sites in China to training MedTech professionals at TÜV SÜD.

Simon is known for delivering practical, efficient, and compliant solutions that help clients move forward with confidence.

Let's connect on LinkedIn

Sophia Hurmann

Operations & Marketing

Sophia ensures that everything runs smoothly behind the scenes. She supports Simon by managing day-to-day operations and coordinating your project needs, including preparing offers, handling inquiries, issuing invoices, and supporting sourcing projects.

In addition, she leads our marketing efforts: from maintaining our website and managing our LinkedIn and YouTube channels to writing our newsletter and communicating customer requirements internally.

Her focus is on providing a smooth, proactive, and personalized experience for every client.

Let's connect on LinkedIn

Our Network – Your Advantage

Our strength lies in the power of our network.

We currently collaborate with 25+ independent MedTech experts who support us on complex, high-impact projects –bringing specialized knowledge, flexibility, and execution power to the table.

In addition, our trusted supplier network enables us to source MedTech-compliant components at scale, with a particular focus on injection-molded parts and other critical disposables.

Thanks to this strong network, we’re able to deliver fast, reliable, and cost-effective solutions that help our clients move quickly and stay compliant.

Our Vision

To shape the future of MedTech by building a global ecosystem of quality and supply chain experts – empowering companies to bring safe, effective, and compliant products to patients faster and with confidence.

Our Mission

To drive success for MedTech manufacturers by turning regulatory complexity into clarity and action. Through deep expertise, a trusted global network, and a hands-on approach, we deliver innovative, timely, and compliant solutions that increase patient safety and move businesses forward.

Respect

Strong relationships are built on trust and respect. Whether with customers, suppliers, or team members, open, honest, and equal communication is the standard we live by.

Result-Oriented

The priority: bringing safe medical devices to market efficiently, without compromise. Every decision balances patient safety with the economic impact on your business to deliver results that are both compliant and commercially smart.

Clarity

In MedTech, clarity is strength. Complex systems and unclear processes increase the risk of failure. Clear requirements, focused actions, and practical solutions are what lead to safe, compliant, and successful products.

Openness

Openness drives progress. Embracing change, fresh ideas, and global perspectives keeps our thinking sharp and our services at the cutting edge. Continuous development ensures that every solution reflects the latest innovations and adheres to the most up-to-date compliance standards.

MedTech Blog

Want to stay one step ahead in MedTech quality and supplier management? In our blog, we share our expertise — practical tips, best practices, and insights on test method validation, process validation, risk management, and more.

All blog posts

Test Method Validation

Simon Föger | May 30 | 8 min

Test Method Validation (TMV) in Medical Device Manufacturing

In this article, you'll learn the essentials of test method validation in medical device manufacturing. We'll explain what test method validation (TMV...

Risk Management

Bernhard Lindner | Jun 03 | 17 min

Medical Device Risk Management: How to Create a MedTech-Compliant Risk Management System According to ISO 14971:2019

In the medical device industry, ensuring patient safety while complying with regulatory requirements is paramount. One of the most critical elements i...

Test Method Validation

Simon Föger | Jun 04 | 9 min

Developing Robust Visual Inspection Processes in the Medical Device Industry

Visual inspection is a cornerstone of quality assurance in the medical device industry, ensuring product integrity, patient safety, and regulatory com...