The core activity of Spierings Orthopaedics BV is the production of surgical instruments and implants. To create high quality and competitively priced products, production is organized by outsourcing parts of the production process to specialized vendors. Other parts of the production process such as finishing, assembling, packaging and clean room activities are performed in house. Spierings Orthopaedics’ products comprise from individualized clinical prototypes to large-scale production.
Spierings Orthopaedics BV works according to the EC-MDD 93/42 and is ISO 13485 certified. CE-files, Device Master Records and Batch Manufacturing Records are standard items in our production process. Spierings Orthopaedics BV has a fully certified Quality Management System according to ISO 13485: 2003.
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
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