ChoiceSpine received ISO certification for its quality management system.
Here are five quick notes:
1. ChoiceSpine received ISO 13485:2003 and BS EN ISO 13485:2012 certification.
2. The certification demonstrates a quality management system that meets regulatory requirements.
3. The certification also signifies customer requirements, risk management and maintaining effective processes specific to the safe design, manufacture and medical device distribution.
4. The certification facilitates compliance to the requirements of customers and various global regulators.
5. ChoiceSpine focuses on spinal implants, including cervical spine systems, interbody implants, minimally invasive spine surgery and anterior cervical plating systems. ChoiceSpine released the BLACKBIRD Posterior Cervical System earlier this month.