Service: Clinical

Quality Advice
...Regardless of Stage

Cost-effective, audit-ready systems
01.
Design & Development
02.
Design Freeze
03.
Verification & Validation 
04.
QMS Effectiveness - Manufacturing
From Startup to Fortune 500 our quality management professionals are here for you at every step.

How Do We Engage?

Man in Plant (MIP)
Dedicated Proxima employees acting as your quality employees
Advisory Consulting
Working alongside your team in a consultative fashion
Oversight
Providing management and oversight of your activities
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
Position
First & Last Name
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
Position
First & Last Name
We joined forces with Proxima's Quality Consultants to ready ourselves for upcoming audits of both our QMS and our parent company's QMS. Their approachable, expert team delivered essential support and insightful guidance, never shying away from directing us confidently towards the right path. We are proud to share our spotless ISO 13485 recertification audit, a testament to Proxima's steadfast commitment and fearless leadership!
Regulatory & QA Manager
Michael Selva
I consider myself quite lucky that when I started as Director of Quality at our innovative SaMD start-up, we already were working with Proxima and Ellie Reynolds. It was invaluable to me to have a knowledgeable, collaborative and responsive partner in Ellie to help me build our QMS and to provide hands-on training in our eQMS, Greenlight Guru. Another great benefit of partnering with Proxima was that when extra help or expertise was required, Ellie always was quick to connect me with other resources on the Proxima team.
Director Of Quality
Matt Garrity

Typical Engagement Path

Our QMS Roadmap will help provide you with a clear and comprehensive overview of documentation and stages required to build a QMS that meets the applicable laws, requirements, and standards for your product(s). This roadmap will serve as the foundation and guidance for the entire QMS build process.
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Proxima can help you select and build out your QMS from the ground up. This includes important steps like developing, drafting, and reviewing SOPs, forms, templates, and work instructions to help ensure a solid establishment of your QMS.
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Let our experienced team of quality and regulatory consultants conduct a comprehensive review of your Device History File (DHF) records to ensure that they comply with, and provide adequate support for, pursuant regulatory work!  Need help populating the DHF?  We can help with that too.
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Assess where you are with the applicable laws, requirements, and standards. Whether you're breaking into a new market, or just need a sanity check on how you're tracking in the current one, Proxima's quality experts can help you outline gaps or remaining hurdles to get you to the finish line!
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Let us take a little stress out of the auditing process and help you achieve the highest level of quality and safety for your MedTech or biotech product! Our team is committed to providing you with comprehensive and personalized support to help you successfully navigate any audits and ensure that your QMS is compliant!
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Frequently Asked Question

Should sponsors consider anything else in deciding whether or not to conduct a study that may fall within the exercise of enforcement discretion?
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Glossary

Sunshine Act
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Latest INsight

Clinical Trials: Risky Business
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Latest Video

Top 5 Considerations When Selecting a CRO for MedTech or Biotech Companies
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Looking for some extra QMS support?
Work with our experienced experts.
Speak with a Quality Management expert