Our Services
Expert consulting services tailored to your business needs, providing strategic solutions and actionable insights. Enhance performance and speed time to market with process-driven efficiency from early development to post-market surveillance.
QMS Process Development
We help life science, medical device, pharmaceutical, and high-tech companies build robust Quality Management Systems from the ground up. Our services include the development of tailored quality processes and the creation of clear, compliant procedure documentation aligned with ISO 13485, ISO 9001, FDA 21 CFR, CLIA, and other global standards. Whether you need to establish new SOPs, streamline existing workflows, or implement scalable documentation practices, we ensure your QMS is practical, audit-ready, and designed to support long-term growth and regulatory compliance.
eQMS Implementation
We provide end-to-end support for adopting electronic Quality Management Systems, including vendor selection, system configuration, and full validation. Our focus is on building compliant, efficient, and user-friendly solutions that meet FDA 21 CFR Part 11, ISO 13485, and other global regulatory requirements. From SOP automation to CAPA tracking and audit readiness, we ensure your eQMS strengthens quality culture and scales with your business.
PLM System Implementation
We help companies select, implement, and validate Product Lifecycle Management systems that unify engineering, operations, and quality. Our services include vendor evaluation, system configuration for hardware, software, and combination products, and compliance validation. With expertise in phase-gate design control, BOM management, CAD/ECAD integration, and change control (ECR/ECO/Deviations), we ensure your PLM drives innovation while meeting strict regulatory and business requirements.
Quality System Audits, Gap Analysis
We provide independent, in-depth audits and gap analyses to assess compliance with FDA, ISO, CLIA, CAP, and other global regulatory standards. Our services cover internal audits, supplier audits, and full QMS evaluations, with clear, actionable recommendations to close gaps and strengthen compliance. Beyond auditing, we also prepare organizations for accreditation surveys and regulatory inspections—helping you anticipate auditor questions, review documentation, and rehearse processes so your team is confident and inspection-ready.
Audit & Gap Analysis Focus Areas:
Document Control & Records Management
Training & Competency
CAPA & Nonconformance Management
Supplier Qualification & Monitoring
Risk Management & Design Control
Equipment & Facility Controls
Management Review & Continuous Improvement
Production, Process Control & Validation
Post-Market Surveillance & Complaints Handling
ISO Certification Preparation
We prepare organizations for accreditation surveys and regulatory inspections—helping you anticipate auditor questions, review documentation, and rehearse processes so your team is confident and inspection-ready.
Are you ready for QMSR?
With the FDA’s Quality Management System Regulation (QMSR) replacing the legacy Quality System Regulation (QSR) in February 2026, U.S. medical device manufacturers must now harmonize with ISO 13485.
This alignment makes it the ideal time to pursue ISO accreditation—not only to meet FDA expectations, but also to streamline compliance across global markets.
CAPAs / Audit Finding Remediation
We specialize in helping organizations resolve compliance issues quickly and effectively through Corrective and Preventive Action (CAPA) and audit remediation projects. Our services include root cause investigation, risk assessment, action plan development, and implementation of sustainable solutions that meet FDA, ISO, CLIA, CAP, and global regulatory requirements.
Whether you’re addressing internal audit findings, regulatory inspection observations, or recurring quality issues, we provide hands-on guidance to close gaps, document objective evidence, and build robust systems that prevent repeat findings.
With our support, your organization can turn compliance challenges into opportunities for stronger processes and lasting quality improvement.