niQu Consulting

We guide medical device manufacturers through the regulatory landscape, helping you navigate the intricacies of international regulations and standards.

Why Choose Us?

Expert Knowledge: Our team comprises seasoned professionals with extensive experience in medical device regulations and quality management.
Customized Solutions: We understand that every organization has unique challenges. We tailor our services to meet your specific needs.
Proven Track Record: We are thrilled to have supported countless clients in reaching outstanding compliance milestones and enhancing their quality management practices to exciting new levels.

Our Offer at a Glance

Person Responsible for Regulatory Compliance (PRRC)

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 liaison within the EU, ensuring your products meet EU regulatory requirements. We manage communication with EU authorities, handle documentation, and provide 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, ISO 9001, MDR, MDSAP, and other relevant standards. We identify areas for 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 ensure 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 Assessments

Our GAP assessments identify discrepancies between your current processes, documentation, and regulatory requirements. We provide detailed reports and actionable recommendations to help you achieve compliance efficiently and effectively.

AI Act Assessments

Our comprehensive internal audit services assess your quality management system (QMS) & TD required for compliance with AI Act

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