Services
Management System Consulting
Expert implementation and maintenance of quality and information management systems for medical device manufacturers. ISO 13485, ISO 9001, FDA QMSR, and ISO 42001 — from gap analysis through certification readiness.
Gap Analysis
Clause-by-clause assessment of your current state against ISO 13485, ISO 9001, or FDA QMSR requirements — with a clear remediation roadmap.
QMS Implementation
Building your quality management system from the ground up — policies, procedures, forms, and records structured for audit readiness from day one.
eQMS Selection & Implementation
Evaluating, selecting, and deploying electronic QMS platforms — configured to match your processes, not the other way around.
SOP Writing
Clear, compliant standard operating procedures written for the people who actually have to follow them — not just for the auditor.
Design Controls
DHF structure, design reviews, and V&V planning per ISO 13485 §7.3 and FDA 21 CFR 820 — built to survive scrutiny.
Risk Management
ISO 14971 risk files, FMEA, and risk-benefit analysis — structured to support your design process, not just satisfy a checkbox.
Supplier Qualification
Supplier evaluation protocols, qualification records, and ongoing monitoring programs — so your supply chain doesn’t become your audit finding.
CAPA System
Designing and operating an effective corrective and preventive action process — one that closes findings and demonstrates continual improvement.
Ready to Build a System That Works?
Whether you’re starting from scratch or fixing what’s broken, let’s find the right approach for your organization.