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Quality

Our team sets itself apart by utilizing proven procedures and processes, ensuring a solid foundation for your quality system. Our partners’ quality systems using our processes pass multiple audits (FDA Audits, ISO 13485 audits, MDSAP, EU MDR, etc.) every year.

Utilizing fractional staffing, we can save our partners on average 28% in staffing costs per year.  These savings provide critical money that can be spent to upgrade Marketing, R&D, or any other critical company initiatives, with no degradation of the quality of company. 

Whether you need QMS installation, real-time management, fractional staffing, audits, or remediation, we have solutions to meet your needs.

Why Choose Us

Clean Bubbles

1

Proven System

Your system is tested and audited by multiple global regulatory agencies each year. 

Since the same quality system is used at multiple companies, learnings and efficacy is immediately shared. 

This produces a rigorously tested and always compliant quality system with reduced effort for your organization.

2

Efficient

Organizations utilizing our quality processes don’t have to experience “first time” issues.

With so many organizations using a similar base quality system, what is a “first time” event to one company has likely been done by another company.

Those learnings and best practices are carried over to help reduce any “first time” effects.

This makes the overall quality system adaptive and efficient.

3

Cost Effective

Utilizing similar, proven processes, as well as fractional staffing provides a huge cost savings to organizations. There are less “first time” events. Fractional Staff gains experience at an exponential rate compared to traditional staff simply because they are exposed to multiple companies at the same time.

In addition, Fractional Staffing reduces downtime and loss of productivity in the event of an employee’s exit. Since there are already trained and experienced staff immediately ready to fill the departing employee’s role. These are just a few of the many ways companies save expenses with Fractional Staffing.

Services

FDA AND ISO 13485:2016 QMS DEVELOPMENT

Do you need a quality management system for medical device development? Do you need the system to be simple and cost effective, yet still meet regulatory requirements? We can help you. We provide daily management of quality systems for ourselves, as well as other medical device companies. So, we are experts at developing effective systems that are simple to manage and meet all regulatory requirements.

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