Quality

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

• animal testing
• clinical trials
• CE registration according to MDD 93/42/EEC of 14 June 1993 and MDD 2007/47/EG of 5 September 2007
• FDA registration

Both companies have a fully certified Quality Management System according to the ISO 13485:2003 standard, these certificate are downloadable.

The scope of Spierings Medische Techniek BV is:
Research and development, prototype manufacture and service of medical devices to be used for orthopedic, trauma, plastic and general surgery appliances

The scope of Spierings Orthopaedics BV is:
Design, manufacture and sales of medical devices for orthopedic, trauma, plastic and general surgery appliances