Building scalable quality systems that power innovation and growth.
Quality Management Systems Consulting
We partner with life science, medical device, pharmaceutical, and high-tech companies to build, strengthen, and scale their Quality Management Systems.
Our services cover the full spectrum of quality and regulatory needs—including QMS process development and documentation, eQMS and PLM system selection and implementation, quality system audits and gap analysis, inspection readiness, and CAPA/audit finding remediation.
With deep expertise in FDA, ISO, CLIA, and CAP requirements, we help ensure your systems are compliant, efficient, and audit-ready—while supporting long-term growth and innovation.
ISO Certification Preparation
We prepare companies to achieve and maintain ISO accreditation with a focus on ISO 13485 (medical devices), ISO 9001:2015 (quality management), and ISO 15189 (medical laboratories). Our services include gap assessments, documentation development, process alignment, internal audits, and readiness coaching to ensure a smooth accreditation journey.
Whether you are preparing for your first certification or renewing accreditation, we provide the expertise, structure, and hands-on support needed to get your quality management system audit-ready and internationally recognized.
