Quality Management Services
for
Medical Devices
About Qualomics
Our mission is to add value to your organization.
What We Do
Quality System Consulting
Strategic planning
QA operations
Off-the-shelf SOPs
QMS development
Process Validation
Master Validation Plan
Equipment IQ/OQ/PQ
Software validation
Off-the-shelf and bespoke protocols and reports
Auditing
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 ESG NextGen
Give Yourself an Edge
Are you ready to sharpen your skills and navigate your way to success in the medical device industry?
Introducing Qualomics Edge, the ultimate tool for compliance, training, and community in medical device quality systems.
Latest Articles
Stay ahead in the medical device industry with insights tailored to your business. Explore our latest articles for strategies, tips, and updates designed to help you enhance efficiency and maintain a competitive edge.
What does GMP-Exempt Mean?
Beyond the 510(k): Why "GMP-Exempt" Status Matters in Medical Device Classification Navigating the world of medical device regulation can feel like deciphering a complex code. You're likely familiar with device classes (Class I, II, and III) and submission types like...
Your Data, Your Responsibility: FDA’s Warning on Third-Party Lab Failures
Data Integrity Crackdown: FDA Tightens Oversight on Third-Party Lab Testing Medical device manufacturers received a serious wake-up call this year: the FDA is rejecting study data from two Chinese labs after uncovering widespread data integrity violations. The message...
Risk Inputs in ISO 13485
ISO 13485 Made Simple: Using Risk to Guide Your Quality System ISO 13485 requires that medical device companies use a risk-based approach in their quality systems. That means the more risk something poses to product safety or compliance, the more carefully it needs to...
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
