Quality Management Services
for
Medical Devices
About Qualomics
Our mission is to add value to your organization.
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
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.
Risk Inputs in ISO 13485
In ISO 13485, a risk-based approach is a cornerstone for ensuring the effectiveness and compliance of a Quality Management System (QMS). This approach means that actions, controls, and evaluations be proportionate to the risks associated with specific processes,...
How-to: Facility Registration
How to Complete FDA Annual Facility Registration: A Step-by-Step Overview This video highlights the step-by-step process for completing the FDA annual facility registration, a mandatory requirement for medical device businesses operating under FDA jurisdiction. The...
Value of Supplier Audits
Are Supplier Audits Required? No Neither ISO 13485 nor FDA 21 CFR explicitly require supplier audits, although supplier audits are one mechanism of qualification. The requirements established in FDA and ISO rules are: • Companies must define evaluation and selection...
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
