We currently offer the test method validation step-by-step guide for the following test methods:

• Dye Penetration Test according to ASTM F1929-23
• Seal Strength Test according to ASTM F88/F88M-23
• Bubble Test according to ASTM F2096-11
• Visual Inspection according to ASTM F1886/F1886M-16

More trainings are coming in Q4/2025.

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This is an important question. You might think you can source materials cheaper when you buy directly from the supplier. 

In some cases, this might be right. However, in all our current cooperations, we found materials at more competitive prices than the customer's current suppliers (in some cases, even 70% cheaper – possible through already established business relationships). 

Also, you will not have to worry about compliance. We ensure suppliers comply with MDR 2017/745 and provide the relevant documentation (Process Validation, Test Method Validation, First Article Inspection, Audit Reports).

Further, you have one reliable contact person (speaking German & English) who ensures your suppliers comply with regulations and conducts supplier audits. 

In many cases, a cooperation with SIFo proves to be more efficient, saves you time & cost, gives you more flexibility, and reduces your risk of non-compliance.

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. 

Our expertise covers critical quality areas in the medical device industry, including:

• Design Control / Product Development
• Test Method Validation
• Packaging Validation
• Process Validation
• Risk Management

We offer both remote and on-site support, depending on your project requirements. While most of our work is conducted remotely, we are happy to arrange on-site availability when needed to ensure effective collaboration.

Our online trainings are tailored for professionals in the medical device industry who are responsible for quality and regulatory compliance. 

This includes quality engineers, regulatory affairs specialists, process development teams, validation engineers, and QA/RA project managers.

Whether you're working in a startup, SME, or established manufacturer, our trainings provide practical, ready-to-apply knowledge to support your role and accelerate project execution.

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.

Our certified auditors conduct supplier audits acc. to ISO 13485. We will independently plan and implement the audit on-site at your supplier and provide you with the documented audit results.

Adequate quality support accelerates time-to-market by ensuring that regulatory requirements are addressed proactively.

We help you build a lean, audit-ready quality management system that reduces rework and delays.

By integrating compliance and risk management early in the development process, you minimize late-stage surprises and gain faster regulatory approvals.

Our online trainings are designed specifically for professionals in the medical device industry who want efficient, practical, and compliant solutions.

All content is created by experts with hands-on experience in FDA, MDR, and ISO 13485 compliance, ensuring it's not only theoretically sound but also operationally effective. 

Currently, we are mainly sourcing in Asia. However, according to your requirements, we will be happy to find and audit suppliers in other regions as well.

SIFo Medical is located in Telfs, Tyrol, Austria.

Yes, a certificate of completion is available upon request. It confirms your participation and can be used to support internal training records.

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.

We source all kinds of parts and components intended to produce medical devices. 

To give a few examples: currently, we are actively sourcing cables, PCBA (Printed Circuited Board Assemblies), and all kinds of disposables.

We don't offer standardized consulting packages. Every collaboration begins with an initial consultation to understand your current situation and define the outcomes you're aiming for.

Based on that discussion, you'll receive a tailored offer with pricing based on the scope, duration, and complexity of the work.

For specific inquiries, feel free to contact us directly at office@sifo-medical.com.

Why it's worth working with SIFo Medical:

An investment in quality management support often pays off quickly. Our clients typically accelerate progress by applying proven best practices and benefiting from hands-on, experienced support. Plus, an external perspective can be invaluable, especially when internal teams feel stuck or overwhelmed.

Yes, for tailored in-house trainings, please contact us directly at: office@sifo-medical.com 

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

This depends on the complexity of the components. 

For some customers we were able to source parts within a few days.

For others, where the complexity of the product is higher, it might take up to several months. However, through our extensive network we are usually able to find suitable partners for you promptly.

Every cooperation starts with an online meeting. Before we start working together, it is vital to us to get to know you in person, and learn about your company, challenges and concerns. Also, we want to clarify all your questions personally.

Head over to our calendar and sign up for your initial consultation.

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