Merger & Acquistion Integration

Acquisitions & Divestitures — Quality & Regulatory Due Diligence

Medical device mergers, acquisitions, and divestitures carry significant quality and regulatory risk that can directly impact deal value, integration timelines, and post-close compliance standing. We provide specialized quality and regulatory expertise to help buyers, sellers, and investors make informed decisions and execute seamless transitions.

What We Offer

Pre-Transaction Due Diligence

• Quality System Due Diligence — We conduct an independent assessment of the target company's quality management system against FDA 21 CFR Part 820, ISO 13485, and applicable global standards — identifying gaps, risks, and liabilities that could affect deal valuation or require post-close remediation investment.
• Regulatory Compliance Assessment — We evaluate the target's regulatory history, including FDA inspection records, Warning Letters, 483 observations, consent decrees, import alerts, and global compliance standing — surfacing material risks before the transaction closes.
• Product Portfolio Review — We assess the regulatory status of the target's product portfolio, including 510(k), PMA, and CE marking status, technical file completeness, and the viability of maintaining or transferring existing clearances and approvals.
• Risk Quantification & Remediation Scoping — We translate quality and regulatory findings into actionable risk summaries and cost estimates for remediation, giving deal teams and leadership the information needed to negotiate terms, structure escrows, or make go/no-go decisions.

Post-Transaction Integration & Separation

• QMS Integration Planning & Execution — We lead the integration of acquired quality management systems into the parent organization's QMS framework, harmonizing procedures, records, training, and quality infrastructure while maintaining continuity of regulatory compliance.
• Site & Product Transfer Support — We manage the quality and regulatory workstreams associated with manufacturing site transfers, product line migrations, and supply chain transitions — including design history file transfers, process revalidation, and regulatory notification obligations.
• Divestiture Readiness — We prepare quality systems, technical documentation, and regulatory files for clean separation — ensuring the divested entity or product line is positioned for a smooth handoff with full regulatory continuity.
• Regulatory Transfer & Notification Management — We manage the transfer of FDA registrations, device listings, 510(k) clearances, PMAs, and CE certificates — coordinating with FDA, Notified Bodies, and international authorities to maintain uninterrupted market access throughout the transaction.
• Standalone Quality Infrastructure Build — For carve-outs and spin-offs, we design and implement the quality management infrastructure needed to operate as an independent, fully compliant medical device company from day one.
• Post-Close Remediation Program Management — We lead structured remediation programs to address quality and regulatory gaps identified during due diligence, managing timelines, resources, and deliverables to resolve issues efficiently and restore full compliance.

Why It Matters

Quality and regulatory issues are among the most common sources of deal risk in medical device transactions — yet they are frequently underestimated or discovered too late. Unresolved compliance gaps can trigger FDA enforcement actions, delay product approvals, restrict manufacturing operations, and erode the value of the acquired business. Conversely, a well-prepared seller with a clean compliance profile commands greater confidence from buyers and smoother deal execution. Expert quality and regulatory support at every stage of the transaction protects your investment and accelerates your path to value.

Who We Serve

We work with medical device companies, private equity firms, investment banks, and corporate development teams on the buy side, sell side, and post-close integration — across transactions of all sizes and complexity levels.