Regulatory Compliance Experience
NeoMetrics holds numerous 510K clearances for a variety of guidewire designs. Our design approach provides flexibility that can be customized to meet your regulatory documentation and submission needs. Alternatively, we can meet the full spectrum of requirements with our fully integrated ISO 13485:2003 design control system.NeoMetrics complies with the following standards:
- FDA Registered Facility
- FDA Quality Systems Regulation (QSR) 21CFR 820 Compliant
- ISO 13485:2003 Certified
- 93/42/EEC European Medical Device Directive (MDD) Certified
- 510k approvals for a variety of clinical guidewire applications