Practice Areas

Our Practice Areas

Grounded in hands-on regulatory and quality work, delivered without the overhead of a large enterprise firm.

FDA 510(k) 21 CFR 807 EU MDR 2017/745 Q-SUB

Regulatory Strategy & Global Submissions

Pre-market and post-market strategy built on the fastest defensible pathway to market.

• 510(k) traditional and special submissions
• Premarket Approval (PMA) strategy and modular review planning
• De Novo classification requests

• Pre-Submission (Q-Sub) strategy and briefing packages
• EU MDR technical documentation (Annex II and III)
• Global market access sequencing across the US and EU

Run the EU MDR Technical Dossier Diagnostic

FORM 483 WARNING LETTER 21 CFR 820.100

Crisis Management & Remediation

Leadership when the stakes are highest, from the first finding by the FDA or a Notified Body through verified recovery.

• Form 483 response strategy and drafting
• Warning Letter remediation planning and execution
• Nonconformance and complaint investigation

• CAPA overhauls, from root cause through effectiveness checks
• Compliance recovery in consent-decree environments
• Recall execution and distribution deviation management

CAPA Architecture, In Depth Run the Inspection Readiness Diagnostic See the Warning Letter Data

21 CFR 820 / QMSR ISO 13485:2016 MDSAP ISO 19011:2018

QMS Design & Auditing

QMS design, overhaul, and auditing led by an ISO 13485:2016 Lead Auditor.

• QMS design and overhaul under 21 CFR 820 (QMSR) and ISO 13485
• MDSAP readiness

• Internal and external audit leadership, including mock audits
• Health authority inspection readiness

QMSR Compliance, In Depth Run the QMSR Diagnostic See the QMSR Citation Data

21 CFR 820.30 ISO 14971 DHF

Design Controls & V&V

Design history files, risk management files, and verification and validation protocols that hold up under regulator, notified body, and audit review.

• Design history file (DHF) construction and remediation
• Risk management files per ISO 14971

• Verification and validation protocol authoring and execution oversight
• Cross-functional engineering governance

Run the Design Controls & V&V Diagnostic

21 CFR 820.30(i) CHANGE CONTROL

Change Control & Lifecycle Governance

Determining whether a design or manufacturing change needs a new regulatory submission or can proceed as a documented update, before that call becomes an inspection finding.

• Impact assessments for proposed changes
• Design change evaluations across hardware, software, and materials

• Regulatory gap analyses ahead of implementation
• Change control board advisory

Change Governance, In Depth Run the Change Control Diagnostic

Scope Your Needs

Most engagements start with a diagnostic conversation, not a proposal. Bring the situation as it stands.