Spierings Medical Technology

Spierings Medische Techniek BV has the technical and medical know how in-house to perform various research and development assignments. Some examples of the assignments are shown below. The scope of Spierings Medische techniek BV’s activities is: “Research and development, prototype manufacture and service of medical devices to be used for orthopaedic, trauma, plastic and general surgery appliances.”

Expertise

• Design and development of surgical implants and instruments
• Production and testing of prototypes
• Static and dynamic material testing
• Bone cement development and evaluation
• Climate room testing
• Design of surgical hydraulic and pneumatic power tools
• Patent research and applications
• Implant testing in a human cadaver bank

Engineering

Spierings Medische Techniek BV is specialized in engineering and development of medical devices. Throughout the years and in numerous projects Spierings has gathered specific knowledge of and experience with developing, testing an producing a high variety of surgical implants and instruments, including:

• Hip, knee, wrist and finger prostheses
• Trauma devices
• Revision instruments
• Bone grafting instrumentation
• Biodegradable cement stops
• Bone cements
• Vacuum mixing systems
• Bone lavage systems

Extensive expertise and facilities are available for biomaterials research and product testing.

The design process of Spierings Medische Techniek BV is fully recorded according to the quality manual. The design process is documented by a registration of the design history file. The design history file consists of a description of a design team, design input, design output, design verification, design validation, design release and design change after market introduction. With this method the design process is controlled as much as possible.

For obtaining certification of medical devices we can assist you with:

• Animal testing
• Medical device testing
• Clinical trials
• CE registration according to MDD93/42/EEC of June 14th and MDD
2007/47/EC of September 5th 2007
• FDA and TGA registration