Quality Management Services
for
Medical Devices
About Qualomics
Our mission is to add value to your organization.
Qualomics provides quality and regulatory support for medical device companies, from startups building their first quality system to established organizations with a specific gap to fill.
We understand the unique position our clients are in. You don’t need another consultant to tell you what’s wrong. You need the right expertise, at the right time, for the problem in front of you.
A successful quality system works for you. It integrates operations, quality, and regulatory instead of sitting apart from them.
What We Do
Quality System ConsultingÂ
Strategic planning
QA operations
Off-the-shelf SOPs
QMS development
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
Years in Medical Devices
Clients Served
Audits Performed
How We Do It
Support that
scales to the work.
Many of our clients partner with us for years, relying on our expertise when a full-time internal hire isn’t necessary. Whether you need a long-term fractional Quality Manager or targeted help with a specific project, we scale our support to fit your exact needs.
Ongoing Engagements
Fractional Quality Manager
ISO certification
Day-to-day QA
Strategic planning
Projects & Off-the-Shelf
Audits and audit responses
CAPA closure
Process improvement
Training & document packages
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.
When a Line Extension Becomes a New Device
A recent FDA warning letter shows what separates a defensible letter to file from a thin one. The difference is the d...
A New Statutory Attempt at LDT Oversight
HR 8890 would keep LDT oversight with CMS under CLIA and add a public validation database, serious harm reporting, an...
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...
What is the difference between RA & QA?
What’s the Difference Between Quality Assurance and Regulatory Affairs? If you’re navigating compliance in a smal...
How to Hold a Management Review
Streamline your next management review with our free agenda template. Designed to meet both FDA and ISO 13485 require...
How to Find a Contract Manufacturer
Learn how to search the FDA Establishment Registration & Listing database to verify device manufacturers, suppli...
2025 FDA Warning Letter Trends
FDA warning letters in the first half of 2025 highlight recurring issues with Medical Device Reporting and complaint ...
What is a Risk-Based Approach?
Risk-based thinking is more than a buzzword, it is the foundation of a smart and effective QMS. This post shows how t...
What Does GMP-Exempt Mean?
GMP exemption status is often overlooked but critically important in medical device classification. This post explain...
Your Data, Your Responsibility
Update, August 2026: A third lab, and a distinction worth understanding On June 25, 2025, FDA issued a Good Laboratory...
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...
How-to: Facility Registration
How to Complete FDA Annual Facility Registration: A Step-by-Step Overview This video highlights the step-by-step...
Value of Supplier Audits
Are Supplier Audits Required? No Neither ISO 13485 nor FDA 21 CFR explicitly require supplier audits, although...
LDT and IVD Info Hub
!!UPDATE MAR 31, 2025 - The LDT Final Rule was overturned in court!! Get more info from ACLA ...
Warning Letters
Update: This post was written in October 2024 when FDA first announced the action. FDA has since gone further,...
Let’s Get Started
Questions?
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