QUALITY MANAGEMENT

ISO 13485 and ISO 9001 Expertise – Compliance You Can Trust / Performance You Can Measure

​​​

At Landrich Group, we deliver expert QMS solutions led by ISO 13485-certified lead auditors, and expert in ISO 9001 ensuring alignment with FDA, EU, and global regulatory standards. Our team brings deep expertise in regulatory submissions, system design, and inspection readiness. Whether you're building a QMS from the ground up or scaling for growth, we help you stay compliant, efficient, and audit-ready—every step of the way.

 

QMS Assessments & Audit Readiness

Conduct QSR, ISO 13485, and ISO 9001 gap assessments as well as FDA and BIMO mock inspections to identify compliance risks and improvement opportunities. We build customized audit strategies to help you prepare with confidence.

 

QMS Development & Implementation

Design and implement quality systems aligned with FDA and other National Competent Authority (NCA) expectations. From document control and training to design control and risk management, we ensure your QMS is practical, scalable, and inspection-ready.

 

System Validation & Compliance (EDC/eTMF)

Support the validation, documentation, and QMS integration of electronic systems such as EDC and eTMF to ensure compliance with 21 CFR Part 11, Annex 11, and FDA expectations. We help establish system controls, user access procedures, SOPs, and training protocols—ensuring data integrity and audit readiness.

 

Design History & Technical File Audits

Audit Design History Files (DHF) and Technical Files to verify completeness, traceability, and regulatory alignment.

​

Site & Vendor Audit Execution

Develop audit plans and conduct internal audits and vendor/supplier audits to evaluate compliance, identify gaps, and guide timely remediation.
 

Ongoing Quality Oversight

Offer strategic quality leadership through cross-functional collaboration, regulatory support, and investor-readiness documentation. We act as an extension of your internal quality team, providing scalable support during critical growth or transition phases.

​

Our Quality Services help you turn complex requirements into actionable, effective systems—ensuring your organization grows with compliance, efficiency, and confidence.