Quality Consultancy

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. This certificate can be downloaded:

ISO Certificate Spierings Medische Techniek (SMT) B.V.

ISO Certificate Spierings Orthopaedics (SO) B.V.

Expertise

• Production of implants
• Production of instruments
• Clean room facilities
• Regulatory affairs
• Clinical trials
• ISO certified
• CE marking

Support

Do you have any questions regarding our products? Please feel free to contact us

+31 (0)24 350 1603

info@spierings.biz