Our Expertise

Founded by a technical leader with over 15 years of experience leading complex medical device programs in FDA regulated environments. Our experience includes leading a $100M Class II Medical Device by navigating complex regulatory challenges to deliver successful FDA approval and commercial launch. With direct FDA interaction experience, deep expertise in V&V and DHF remediation, and a systematic understanding of what regulators look for, Platinum AI brings a level of technical credibility that most consulting firms simply can't match.

Core Credentials and Experience:

• Led a $100M Class II Medical Device, FDA approval and commercial launch

• Led a $40M product launch for a Class II Medical Device in Canada through full regulatory approval

• Reviewed and tracked hundreds of FDA 483 observations over 15 years and built a systematic tracking tool to identify patterns in FDA findings

• Direct FDA interaction, answered agency questions during new product submissions

• 15+ years in FDA and ISO regulated medical device environments

• Deep expertise in DHF remediation, V&V, IQ/OQ/PQ, and regulatory compliance

• Led cross-functional engineering teams as program and project manager, driving scope, schedules, budgets, and key milestones across complex medical device programs

• Partnered with senior leadership to provide program updates, align cross-functional teams, and ensure execution exceeded program goals in FDA
  regulated environments