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Regulatory

Expertise

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Our Vision

We believe that medical device start-ups should have access to the same high-caliber Quality and Regulatory expertise as large corporations.  We bring decades of experience and expertise when you need it and in the right size package.

Our Story

At Apsis Consulting Group, LLC our passion is helping entrepreneurs launch their medical devices in the US market and helping their operations hold up to regulatory scrutiny. We give our clients peace of mind so they can focus on running their business.

Our Experience

We are a team of experienced scientists and engineers who designed medical devices, optimized manufacturing operations and audited world class manufacturers for compliance.  If there's a job in QA/RA we've done it.

Who are we

30

CUSTOMERS ADVISED

180+

MEDICAL DEVICES WORKED ON

3

AVAILABLE

CONSULTANTS

50+

YEARS OF MEDICAL DEVICE EXPERIENCE

 Regulatory Support

 

Whether you need help with determining a regulatory pathway, compiling a 510k or any questions along the way, we can help.

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Quality Support
 

Do you need remediation help?  Need a QMS from scratch?  We have answers to your Quality questions. 

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Auditing

Our team of expert Certified Auditors will scrub your QMS and processes clean to get you in the best shape possible before an audit.  

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Resource Augmentation

If you're team's plate is  is full let us help  with your CAPAs, Validations, MSAs or any other work that's bogging you down. 

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