We offer expert support in EU medical device regulations to simplify your market entry. Our team helps you meet compliance requirements. You can focus on innovation and product development. We manage regulatory affairs. Together, we will aid your success in the medical device industry.
PRRC – Person Responsible for Regulatory Compliance
We act as your designated PRRC, ensuring compliance with EU MDR and IVDR requirements. Our experts oversee your technical documentation, post-market surveillance, and regulatory reporting, ensuring your operations align with European regulations and standards.
Authorized Representative
As your Authorized Representative, we serve as your legal connection within the EU, ensuring your products meet EU regulatory requirements. We manage communication with EU authorities, handle documentation, and offer expert guidance to help you navigate the regulatory landscape seamlessly.
Internal Audit Services
Our comprehensive internal audit services assess your quality management system (QMS) against ISO 13485 and other relevant standards. We find areas of improvement and help you implement corrective actions, ensuring your QMS is robust, compliant, and audit-ready.
Technical Documentation Assessment
We review your technical documentation to verify it complies with EU regulatory requirements, including MDR and IVDR. Our assessment identifies gaps, improves documentation quality, and ensures your product’s market readiness.
GAP Assessment
Our GAP assessments find discrepancies between your current processes, documentation, and regulatory requirements. We offer detailed reports and actionable recommendations to help you achieve compliance efficiently and effectively.
niQu Consulting 