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
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.
Learn MoreProxima 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.
Learn MoreLet 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.
Learn MoreAssess 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!
Learn MoreLet 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!
Learn MoreFrequently Asked Question
What personnel are key to the success of your animal study?
Learn MoreGlossary
Informed Consent Form (ICF)
Learn MoreLatest INsight
Biotech and MedTech Funding Series: Funding an Oncology Startup with CPRIT
Learn MoreLatest Video
Can You Use Your Manufacturer's QMS?
Learn MoreLooking for some extra QMS support?
Work with our experienced experts.
Speak with a Quality Management expert