Revolutionize Your
Medical Device Production

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)

SIFo Medical mainly works with small and medium sized medical device manufacturers that seek 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 - Sourcing

SIFo Medical is located in Telfs, Austria – a small town in the Austrian Alps. However, most of our work can be done remotely. If needed, we also travel to the customer's location.

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 best patient outcomes.

You can contact us via e-mail: office@sifo-medical.com or directly book a call with Simon through our calendar.

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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: https://calendly.com/sifo_medical/initial-consultation-sifo-medical

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 are not offering standardized consulting packages. All of our consulting services start with an initial consultation to find out what the status quo is, and which results you expect. Based on the initial consultation, you will receive an individual project plan which will be charged according to the length and complexity of the project. For further information, please contact us directly at office@sifo-medical.com. On a side note: The investment in QM consulting pays off very quickly. Most of our clients move things forward much faster during our cooperation because they benefit from proven best practices and hands-on support. Also, outside input is often worth its weight in gold when you can't see the forest for the trees. Not only do you save time and spare some nerves, but you can also save costs in the long run through fewer complaints, efficient workflows, and full compliance with regulations.

We source all kinds of parts and components intended to produce medical devices. You can be sure that the supplier fulfills all requirements as requested by the MDR 2017/745 and further critical regulatory requirements. To give a few examples: currently, we are actively sourcing cables, semiconductors, PCBA (Printed Circuited Board Assemblies), and all kinds of disposables.

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.

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.

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.

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.