Quality Management Services
for
Medical Devices
About Qualomics
Our mission is to add value to your organization.
What We Do
Quality System ConsultingÂ
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.
RUOs, LDTs, and FDA Enforcement
Despite the 2025 court decision vacating the FDA’s LDT Final Rule, labs and manufacturers aren’t off the hook. This article explores how the FDA is shifting enforcement to RUO labeling and IVD misuse to maintain oversight of unregulated diagnostics.
What is the difference between RA & QA?
Quality Assurance focuses on internal systems and execution. Regulatory Affairs manages external approvals and regulatory strategy. Both are essential but distinct in scope and often overlapping in practice, especially in small medical device companies.
How to Hold a Management Review
Streamline your next management review with our free agenda template. Designed to meet both FDA and ISO 13485 requirements, it helps ensure compliance, clear documentation, and efficient oversight without starting from scratch.
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
