Chart your regulatory path to market and maintain compliance once you're there. We support FDA, EU MDR, and other international submissions — and partner with you through inspection readiness, audits, and post-market obligations.
Most regulatory engagements show up as submission work. But the submission is usually the last 20% of the regulatory effort — the other 80% is the strategy, the test plan, the labeling, the supporting documentation, and the conversations with the regulatory agencies that happen before any submission.
Our Principals have led global submissions that have enabled commercialization on every continent. This experience began inside medical device companies and has continued with our clients. We've defended decisions to reviewers, responded to deficiencies, and managed the interaction that determines whether a submission moves through cleanly or stalls.
That experience means we know where the real risks lie — and how to design a regulatory program that addresses them before they become a problem.
Handle establishment registration and renewal under 21 CFR Part 807, including the summary of requirements.
Handle device listing and renewal under 21 CFR Part 807.
Serve as US Agent and handle the responsibilities for foreign manufacturers.
510(k), PMA, De Novo, pre-submission strategy — selected based on predicate analysis and pathway assessment.
GUDID submission and ongoing maintenance of device identifier data.
Establish and operate PMS programs, now formally required under QMSR.
Review complaints and report or open CAPAs as needed under 21 CFR Part 820.
Submit Medical Device Reports to FDA per 21 CFR Part 803.
Send out notifications and manage FDA communications during voluntary or mandated recalls.
Respond to citations and warning letters, follow through with remediation and FDA communications.
Assess QMSR compliance and remediate as necessary — linked to QMS work.
Sustaining activities and product lifecycle management for Design History Files (Design and Development Files).
Select and engage with Notified Bodies, including managing the application and assessment process.
Prepare for and support EU MDR audits — linked to QMS audit work.
Author EU MDR-specific procedures: EO, PRRC, Vigilance, CMR/ED, RoHS, REACH, and supporting documentation.
Build and maintain Technical Files, Declarations of Conformity, and GSPR documentation.
Including additional V&V, testing, and engagement with external labs — linked to product development.
Vigilance reporting and complaint management per MDR Articles 87–92.
Develop PMS plans and PSURs (or PMS reports for Class I) per MDR Annex III.
Registration and ongoing submissions across all required EUDAMED modules.
Strategy and submission support for additional regulated markets, working with in-country partners as required.
Coordinate regulatory strategy across FDA, EU MDR, and other markets to maximize reuse of testing and documentation.
Schedule a no-cost consultation. We'll help you map your regulatory pathway or scope a response program.
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