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 Consulting 

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Strategic planning

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QA operations

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Off-the-shelf SOPs

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QMS development

Auditing

 

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Audit preparation

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Internal audits

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Audit responses and remediation

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Supplier and vendor audits and inspections

Adverse Event Reporting

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Streamline eMDR reporting

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Save time and report quickly

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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

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Fractional Quality Manager

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ISO certification

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Day-to-day QA

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Strategic planning

Projects & Off-the-Shelf

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Audits and audit responses

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CAPA closure

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Process improvement

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Training & document packages

Not sure which one you need? Let’s talk.

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.

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Questions?

The only stupid question is the question that is never asked