REGULATION & APPROVALS
European Standart
Advanced medical equipment that holds the European CE certification, which indicates compliance with strict safety, quality, and performance standards. The certification allows for use and marketing in many countries while complying with international regulations.
Ministry of Health Approval
This document confirms that the FixNip NRI implant has been officially reviewed and approved by the Ministry of Health, meeting all required safety, quality, and regulatory standards
This document provides detailed instructions for the proper use, handling, and implantation of the FixNip NRI implant, ensuring safe and effective outcomes for both practitioners and patients.
FixNip IFU
FixNip's clinical benefits, safety profile, and supporting evidence in a clear, accessible format. It is intended to provide transparency for both healthcare professionals and patients regarding how FixNip performs and the risks associated with its use.
FixNip SSCP (Summary of Safety and Clinical Performance)
The FixNip design, manufacturing, and quality management processes comply with internationally recognized standards for medical devices. The FixNip NRI is consistently developed and produced under strict quality controls to ensure safety, performance, and regulatory compliance.
ISO 13485:2016
The Medical Device Single Audit Program (MDSAP) enables a single regulatory audit to satisfy the quality management requirements of multiple participating countries. This certification streamlines international market access and demonstrates FixNip’s readiness to meet the expectations of leading global regulatory authorities.