Quality Management Services
for
Medical Devices
About Qualomics
Our mission is to add value to your organization.
Qualomics provides quality and regulatory assistance to medical device start-ups and small companies where resources are limited and timelines are tight. We offer services for implementation of new FDA or ISO quality systems, inspection preparation, transfer to manufacturing, or internal auditing. A successful quality system works for you and integrates operations, quality and regulatory.
What We Do
Quality System Consulting Services
Strategic planning
Quality Assurance training
QA operations
Off-the-shelf SOPs
QMS development
Process Validation Consulting Services
Master Validation Plan
Equipment IQ/OQ/PQ
Software validation
Off-the-shelf and bespoke protocols and reports
Audit Consulting Services
Audit preparation
Internal audits
Audit responses and remediation
Supplier and vendor audits and inspections
Adverse Event Reporting
Streamline eMDR reporting
Save time and report quickly
Electronic adverse event reporting with WebTrader and eSubmitter
We needed an internal audit ASAP and Qualomics was able to schedule one right away.
Qualomics is easy to work with and we rely on them to keep us in line.
We needed help to ensure our DHR would pass FDA scrutiny and Qualomics delivered.
We lost our QA Manager at a critical time and Qualomics stepped in to get us through some upcoming audits.
Let’s Get Started
Questions?
The only stupid question is the question that is never asked
Introducing eCFR