Integrated solutions

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.

Development

Product Design | Feasibility Studies | Prototype Construction

Together with you, we develop innovative and feasible product concepts - from idea to readiness for mass production.

Production

Engineering | Manufacture | Quality Assurance

We ensure that the design is suitable for production as a medical product and develop the optimum, validated manufacturing process.

Logistics

Globally Active OEM Partner | Individual Labeling | Warehouse Management | Customer-oriented Consignment | Customer-specific Delivery

From individual packages to pallets, from short-term deliveries to consignments - we ship worldwide according to your specific requirements.

Regulatory

Marketing Approval | Quality and Risk Management

We support you with the proof of conformity of your products and take care of compliance with statutory and regulatory requirements.

Wächtersbach, Germany

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: 1,500 m²

Metal Processing | Plastic Manufacturing | Assembly | Packaging | EO Sterilization

Prague, Czech Republic

Our subsidiary company SaFeMed is located in Prague, Czech Republic.

  • Production area: 950 m²
  • Warehouse and administration: 600 m²
  • Clean room area: 900 m²

Metal Processing | Plastics Processing | Assembly | Packaging Management

Designing together: The top management team consists of:

  • Dr. Alexander Dziengel - Managing Director
  • Ralf Blomeyer - Managing Director
  • Siegfried Schäfer – Operations Manager, Authorized Representative
  • Christina Poliart – Sales & Marketing Manager, Authorized Representative
  • Simone Zöller - Human Resources Manager, Authorized Representative

Professionalism across the board - meeting the requirements down to the smallest detail. National and International.

  • Medical devices standard EN ISO 13485:2012/AC:2012
  • 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"