SIFo Medical

SIFo Medical sources components for manufacturing medical devices, allowing device developers to outsource their supplier management.

Through an exclusive network of medical plastic injection moulding companies, cable manufacturers and other original equipment manufacturers (OEMs), we select the right supplier for your needs.

Working with SIFo Medical ensures you will receive:

• Qualitative parts at competitive prices
• Complete documentation covering:
  – Process validation
  – Test method validation
  – First article inspection
  – Audit reports

Quality management services for medical device development

SIFo Medical offers two main services for medical device companies: quality management and supplier management. Whether you want to build up your quality management system (QMS) from scratch or need to cope with short-term bottlenecks, SIFo Medical is actively involved in your projects.

SIFo Medical operates a network of medical component suppliers for our clients to order from.

Our team can offer support in process validation, test method validation, design control, and risk management.

We specialise in connecting clients with suppliers of injection moulding parts, cables, and tools for processing bone cement.

SIFo Medical acts as a single point of contact for our clients, meaning they do not need to work with multiple stakeholders.

All our suppliers comply with US FDA regulations, MDR 2017/745 and ISO 13485 regulatory criteria.

Our experienced team offers hands-on support in process validation, test method validation, product development / design control, packaging validation, and risk management. Internal and external quality experts work with your team to solve quality issues, improve processes, and update the documentation to comply with relevant medical device regulations and standards.

Management of medical device component supply chains

SIFo undertakes the whole sourcing process for you – from finding the right supplier, supplier development and audits to regular supplies of components in high volumes. Our quality experts select the most suitable manufacturer for you, handle the development of customised products, conduct supplier audits, and take over the whole communication with the supplier.

SIFo’s clients are guaranteed maximum security when making sourcing decisions. Regulatory compliance is our highest priority and selection criteria, with all our suppliers complying with US FDA regulations, MDR 2017/745, and ISO 13485.

Short, efficient supply chains to save time and resources

Finding the right supplier is usually a long process that requires resources from your quality and purchasing departments. Due to physical and cultural distance from the supplier, initial communication can be frustrating and sometimes hard to overcome.

SIFo Medical has the necessary knowledge in quality management and an established network of trustworthy suppliers (especially for injection moulding parts, cables, and tools for processing bone cement), which shortens the sourcing process significantly. In some cases, we were able to go into mass production within three months of the client’s enquiry.

Strong relationships with a range of component suppliers

SIFo maintains exceptional business relationships with our suppliers, especially those based in Asian countries. We leverage our network to find tailor-made solutions and negotiate advantageous conditions, while using in-person contact and trust to build the foundation for business.

We provide access to outstanding suppliers, particularly for products like cables, plastic injection moulding, and tools related to bone cement, such as pulse lavage sets and bone cement mixers. Through our network, you will receive all kinds of components intended to produce medical devices, including customised OEM solutions.

One point of contact for all supply chain operations

Instead of dealing with various stakeholders, SIFo Medical will be your single point of contact. Count on a loyal partner by your side who speaks German, English, and Spanish.

By outsourcing your supplier management, you can rely on our quality experts to ensure regulatory compliance while profiting from established business relationships with suppliers that have been audited and tested in advance. As a result, the risks of working with an unknown supplier are mitigated.

About SIFo Medical

Founded in 2020 by quality management expert Simon Föger, SIFo Medical is an Austria-based service provider for medical device manufacturers. SIFo provides hands-on support in quality, risk, and supplier management.

We ensure you comply with medical technology regulations, optimise your production processes, and source compliant components to produce safe medical devices. SIFo works together with an exclusive network of quality experts and component suppliers to bring your QMS to peak performance and secure your supply chain.

If you want to achieve maximum safety in your QMS, become more efficient, and improve your sourcing strategy, please contact us via the enquiry form on this page.