What we do
End-to-End Regulatory Strategy
From pre-submission planning through post-market compliance, we guide medical device companies through the stages of the FDA and International regulatory process.
Regulatory Expertise Across the Full Product Lifecycle
Regulatory Strategies Inc provides specialized consulting for medical device companies navigating the complex FDA and International approval landscape.
Our team of industry veterans brings firsthand knowledge of agency expectations — helping you build submissions that succeed.
IDE Submissions
Comprehensive preparation and management of Investigational Device Exemption applications. We coordinate all technical sections, manage agency correspondence, and optimize submission strategy to minimize review cycles.
510(k) & PMA Pathways
Expert guidance for medical device clearance and approval. We assess predicate device strategies, prepare substantial equivalence arguments, and manage the full 510(k) or PMA submission lifecycle from design controls through post-market surveillance.
Pre-Submission Meetings
Strategic preparation for meetings with FDA. We develop meeting packages, formulate targeted questions, and coach your team to maximize the value of every agency interaction — setting the stage for a successful development program.
Clinical Trial Strategy
Protocol design, statistical analysis plan review, and clinical development planning aligned with FDA expectations. We help sponsors design trials that generate the evidence needed for approval while managing risk and timeline.
Manufacturing Compliance
Biocompatibility, Sterilization, Packaging, Manufacturing, and Quality Controls strategy for device submissions. We review sections, advise on GMP compliance, and prepare responses to FDA manufacturing deficiencies to keep your program on track.
Post-Market Surveillance
Ongoing regulatory support after approval or clearance. We manage annual reports, supplement filings, CAPA programs, and FDA inspection readiness — ensuring continued compliance throughout the product lifecycle.
How we work
A Structured Approach to Regulatory Success
Every engagement follows a proven methodology built on decades of FDA experience.