The Amputee Care Center is a NEN-EN-ISO 13485-certified supplier of medical devices, including prostheses in particular. This is an internationally recognised quality standard that applies specifically to manufacturers and suppliers of medical devices.
This certification means that we:
- Meet the highest safety and quality requirements in the development, production and delivery of orthopaedics and prostheses.
- Work according to standardised processes that are continuously monitored and improved.
- Carefully manage risks at every stage of the prosthetics process, from design to aftercare.
- Guarantee clear documentation and traceability of every device we supply.
- Be legally compliant with the European Medical Device Regulation (MDR) legislation, which strictly controls the quality of medical devices.
As a patient, this means one thing above all: you get a device that is safe, of high quality, and supplied by an orthopaedic company (Spronken) that meets the strictest standards within the healthcare sector. An internationally recognised quality label also gives extra confidence to hospitals and rehabilitation centres that have their own quality label and quality system. Thus, surgeons, doctors, physiotherapists, insurers and other healthcare providers who work with us know that their patients are in safe hands.