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Data Technology

Quality System Auditing Services

The reason to choose Prime Path Medtech as your auditing team comes down to one concept – REAL and CURRENT Experience.

Every single auditor has a current “day-to-day” job of managing a quality system at either one or likely multiple medical device companies. This real time experience means they have experience with real limitations, business pressure, and they that have to defend against regulators every year.

You won’t find “Auditors” that did the “day to day” work 20 years ago and haven’t ever sat on the defense side of the table. Experiences 10 or 20 years ago just aren’t as relevant as current experience.

In fact, all our auditors defend against the FDA and multiple Notified Bodies several times each year due to the nature of our Fractional Staffing Model. This provides an experience multiplier, and the experience is constantly current.

Choose the RIGHT team for your audit.

Why Choose Us

Parallel Lines

1

Real and Current Experience

Most consulting companies use “auditors” that might have worked in a “real” job 20 years ago. And most of these consultants haven’t actually had to defend an audit in decades (if ever). ALL of our auditors currently manage quality system for Medical Device companies today. Therefore, they don’t audit to theories or what worked 20 years ago, but they bring their current, real time experiences to make your company better today.

2

Audit Defense

All of our auditors currently defend and support companies in actual regulatory audits today. It’s one thing to audit a company, however, it is a whole different experience on the other side of the table. Our auditors know that.

3

Business Focused

Since every one of our auditors currently manages quality systems every single day. We understand and empathize with the realities of the business. And we truly understand the dynamics and realities of what is possible, as compared to just having an idealistic and unrealistic view of the world.

Services

FDA QMS (Part 820)  

ISO 13485:2016 

MDSAP 

EU MDR 

Supplier Audits 

Audits to other standards available on request 

Turn Your Medical Device Idea into Reality

Book your free 30-minute meeting now

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