FDA 510(k)
21 CFR 807
EU MDR 2017/745
Q-SUB
Regulatory Strategy & Global Submissions
End-to-end pre-market and post-market strategy, scoped to get a product to market on the fastest defensible pathway, and keep it there.
- • FDA 510(k) traditional and special submissions
- • Premarket Approval (PMA) strategy and modular review planning
- • De Novo classification requests
- • Pre-Submission (Q-Sub) strategy and FDA briefing packages
- • EU MDR Technical Documentation alignment (Annex II/III)
- • Sequencing global market access across US and EU jurisdictions
FORM 483
WARNING LETTER
21 CFR 820.100
Crisis Management & Remediation
Executive-level leadership when the stakes are highest: engaged directly, without layers of account management standing between you and the work.
- • FDA Form 483 response strategy and drafting
- • Warning Letter remediation planning and execution
- • CAPA program overhauls, root cause through effectiveness checks
- • Systemic compliance recovery for consent-decree environments
21 CFR 820 / QSMR
ISO 13485:2016
MDSAP
ISO 19011:2018
Quality Management Systems & Auditing
Comprehensive QMS design, overhaul, and auditing, led by an ISO 13485:2016 Lead Auditor (TPECS certified).
- • QMS design and overhaul under 21 CFR 820 (QMSR) and ISO 13485
- • MDSAP program readiness
- • Internal and external audit leadership, including mock audits
- • Health authority inspection readiness
21 CFR 820.30
ISO 14971
DHF
Design Controls & Verification/Validation
Technical writing and engineering governance for the files that regulators, notified bodies, and your own future audits will hold you to.
- • Design history file (DHF) construction and remediation
- • Risk management files per ISO 14971
- • Verification/validation protocol authoring and execution oversight
- • Cross-functional engineering governance
21 CFR 820.30(i)
CHANGE CONTROL
Change Control & Lifecycle Governance
Knowing whether a modification is a documentation update or a new submission is the difference between a controlled change and an inspection finding.
- • Strategic impact assessments for proposed changes
- • Design change evaluations across hardware, software, and materials
- • Regulatory gap analyses ahead of implementation
- • Change control board advisory
