From raw material to the finished sterilized product - our integrated solution approach covers the full range of services: from design to production and packaging, to logistics and regulatory requirements. Our customers benefit worldwide from this approach.
Are you looking for an integrated solution involving the manufacture of disposable medical devices? Besides an optimum development and production process, are the sterile packaging of your products, in line with industry standards, and the observance of regulatory requirements equally as important? Then you have found what you are looking for with sfm.
The sfm headquarters is in Wächtersbach. The largest production facilities are also located there, along with central administration and product development.
- Business facilities: 10,000 m²
- Production and warehouse area: 8,000 m²
- Clean room area (class 8): 1,500 m²
Metal Processing | Plastic Manufacturing | Assembly | Packaging | EO Sterilization
Designing together: The top management team consists of:
- Peter Strötgen - Managing Director, CEO
- Siegfried Schäfer – Operations Director, Authorized Person
- Christina Poliart – Director Sales & Marketing, Authorized Person
- Simone Zöller - Human Resources Manager, Authorized Person
- Dr. Olaf Brömsen - Head of Development & Regulatory, Authorized Person
Our commitment to quality
Professionalism across the board - meeting the requirements down to the smallest detail. National and International.
- Medical devices standard EN ISO 13485:2016
- Requirements of Directive 93/42/EEC (last amended by Directive 2007/47/EC)
- U.S. FDA requirements according to CFR820
- Japanese marketing approval "JGMP"
- Australian directives "Australian Regulatory Guidelines and Standards for Medical Devices"