Quality

 High-quality work based on consistency and transparency

We at SFM have committed ourselves to quality. This goes far beyond legal regulations and specified standards for quality assurance. For exactly this reason, we adhere particularly strictly to the stipulated rules, the obligation to provide evidence and documentation as well as transparency. SFM quality systems are permanently improved and optimised by internal and external audits.

SFM Quality Management – national and EU

Our quality management encompasses the compliance with

• medical devices standard DIN EN ISO 13485:2003
• the requirements of 93/42/EEC
• all legal regulations of national law

which are deduced from this EU guideline, in particular

- the Medizinproduktegesetz (German Medical Devices Act)
- the Medizinprodukte-Verordnung (German Medical Devices Ordinance)
- the Medizinprodukte-Sicherheitsplanverordnung (German Ordinance on Medical Devices Vigilance)

SFM Quality Management - Intercontinental

Furthermore, the following requirements are fulfilled:

• Canadian Medical Devices Requirements
• US FDA/GMP Requirements
• Australian Regulatory Guidelines and Standards for Medical Devices

SFM Quality Assurance

All processes required for the manufacturing of SFM’s products are monitored by a systematically implemented quality assurance system. For that purpose, SFM has an in-house physical and microbiological quality laboratory at its disposal.

If required, external laboratories are also consulted.
Another important goal of our QA system is to integrate quality- and function-relevant design specifications into the product development as early as possible.

The quality of the products and the reliability of the services is the sum of the responsibility of all our employees.