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QUALITY SUPPORT

Quality doesn't have to be overwhelming.  

Let us take the pressure off so you can focus on delivering the best to your patients. 

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FRACTIONAL QUALITY MANAGER

If you're a start-up or small medical device firm you may not need a full-time Quality Manager but would still like the ability to consult with an expert.

 

Our Unlimited Quality Advisory services may be exactly the engagement model your firm needs. 

STAFF AUGMENTATION

Need temporary assistance with short-term project?

We can work with you to add resources for your projects:

Design Control, Process Validation, CAPAs, SOP Development or File remediation.

01. ISO Compliant QMS

Full QMS templates

QSR and ISO13485 compliant

QUALITY TOOLS AND TEMPLATES
We have in-house quality tools to get your QMS right.  Whether you need to start your QMS from scratch or update to a 13485 standard or even merge into an eQMS.  

02. Right-Sized for You

Customized QMS for your firm

Design only the QMS modules you need

03. eQMS

eQMS hosting capabilities

We can host your eQMS if you're ready to

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QUALITY AUDITING

Do you need certified independent auditors?

We have certified staff to meet your auditing needs

  • Internal audits

  • Supplier audits

  • ISO 13485 certification prep

  • FDA QSR mock audits

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QUALITY REMEDIATION

Sometimes things happen. Whether observations comes from the FDA or from a customer you need to take the time and effort to fully eliminate the nonconformance. Whether you're answering an FDA observation, warning letter or other enforcement action  we have the expertise to help.

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