About
Platinum AI is an engineering consulting firm focused on helping organizations successfully deliver complex technical programs from development through launch.
We specialize in design verification and validation, manufacturing process validation, and end-to-end program execution for medical device development.
Our work is centered on ensuring engineering teams stay aligned, risks are identified early, and programs are executed with precision, speed, and accountability.
Beyond execution support, we help companies strengthen their engineering operations through better planning, clearer requirements, improved cross-functional coordination, and scalable team structures.
While our core expertise is in medical devices, Platinum AI also partners with organizations across other engineering disciplines to support a wide range of technical initiatives and delivery challenges.
We work with teams that need more than advice, they need execution support that drives real outcomes.
Engineering Consulting
Platinum AI provides consulting support for next-generation medical device development, including AI-enabled solutions, helping teams improve design, validation, and program execution from concept through launch.
Our Expertise
Platinum AI experience includes leading a $100M Class II drug delivery device program, overseeing the full lifecycle from development through FDA approval and commercial launch. This complex program required navigating significant regulatory challenges and coordinating cross-functional teams across R&D, Quality, and Operations. The successful launch stands as a testament to Platinum AI's ability to execute high-stakes medical device programs from start to finish.
$100M Drug Delivery Device Launch
FDA 483 Expertise
Experienced consultants that reviewed and tracked hundreds of FDA 483 observations across the medical device industry, building a systematic tool to identify patterns in regulatory findings. This unique insight provides Platinum AI clients with an unmatched understanding of what FDA auditors look for during inspections. When you work with Platinum AI, your program benefits from 15 years of regulatory intelligence built from real FDA findings.
Multi-Million Dollar Product Launch in Canada
Platinum AI led a $40M medical device product launch in Canada, navigating the full regulatory approval process and delivering a successful commercial launch in an international market. This engagement required deep knowledge of Canadian regulatory requirements and cross-functional coordination across engineering, quality, and operations teams. The successful outcome demonstrates Platinum AI's ability to execute complex product launches across multiple regulatory environments.
FDA Submissions
Platinum AI has worked directly with the FDA, answering agency questions and responding to findings during new product submissions and regulatory reviews. This firsthand experience navigating the back and forth of FDA submissions gives clients a significant advantage in their regulatory strategy. Most consultants have never spoken directly with the FDA, Platinum AI has.
Testimonials
"The Platinum AI team brought a level of expertise and execution to our validation program that we simply couldn't find internally. From day one they understood our regulatory challenges and delivered audit-ready documentation under an incredibly tight timeline. If you're a medical device company preparing for an FDA submission or product launch, Platinum AI is the partner you need."
VP of Engineering, Medical Device Company
"We brought Platinum AI in to lead our DHF remediation effort and the results exceeded every expectation. Their deep knowledge of what FDA auditors look for made our entire team more confident going into our submission. They don't just consult, they execute. Our program would not have launched on time without them."
Program Manager, MedTech Startup
"Working with Platinum AI has been a seamless experience. They bring a rare combination of technical depth and leadership that makes them the first call I make when a client needs senior level V&V or regulatory support. Platinum AI delivers every time."
Senior Recruiting Partner, Life Sciences Staffing
Contact Us
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