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RQM+
RQM+ was formed in 2014 through the merger of three regulatory consultancies and now operates as the largest pure-play medical device regulatory services firm...
RQM+
RQM+ was formed in 2014 through the merger of three regulatory consultancies and now operates as the largest pure-play medical device regulatory services firm globally. CEO Margaret Keegan, a former FDA branch chief, engineered a roll-up strategy that consolidated fragmented expertise into a single platform covering pre-market submissions, post-market surveillance, and clinical trial design. The firm is backed by Linden Capital Partners, a Chicago-based healthcare private equity firm, which acquired a controlling stake in 2020. The firm's deployment model is built around embedded consulting teams that function as outsourced regulatory departments for medtech companies. Its service lines span FDA 510(k) and PMA submissions, EU MDR compliance, quality systems remediation, clinical trial management, and toxicology risk assessment. Confirmed client-side outcomes include steering heart-valve, orthopedic implant, and diagnostic-device manufacturers through priority review pathways. Geographic reach covers the US, EU, and UK notified body engagements, with particular density in Pittsburgh and Minneapolis—two hubs for medical device engineering talent. In May 2023, RQM+ acquired Giotto Compliance, a software platform that uses AI to map device components against regulatory standards, signaling a move into technology-enabled services. The firm's headcount exceeds 1,200 professionals, per its own disclosures, and it operates adjacent to a Linden portfolio constellation that includes other healthcare-exclusive services platforms. No independent philanthropic arm or family office structure is attached. Structurally, RQM+ differs from generic contract research organizations by concentrating exclusively on medical devices rather than pharmaceuticals. Its consultants include former FDA device reviewers, which gives the firm a proprietary sourcing model for regulatory intelligence — ex-regulators who understand both the letter of the guidance and the unwritten negotiation pathways inside the agency. It is not a fund; it is an operational lever that PE sponsors bolt onto existing platform investments to compress time-to-market, making it a recurring line item in healthcare buyout playbooks.
General information
Firm type
Asset Manager
Year founded
2014
AUM
Undisclosed
Location
Region
North America
Country
United States
City
Pittsburgh
Corporate office
Pittsburgh, PA, United States
Principals
Margaret Keegan
Chief Executive Officer
Randy Horton
Chief Solutions Officer
Sector focus
Frequently asked questions
Who runs investment decisions at RQM+?
RQM+ does not make investment decisions; it is an operating services company, not an asset manager or fund. Financial and strategic decisions sit with its private equity sponsor, Linden Capital Partners, which acquired a controlling stake in 2020. CEO Margaret Keegan runs daily operations and M&A strategy, which includes acquiring smaller consultancies and technology platforms like Giotto Compliance.
How does Linden Capital Partners use RQM+ inside its portfolio?
Linden typically installs RQM+ as the regulatory and quality infrastructure inside its medtech platform companies immediately post-acquisition. The firm runs gap assessments, remediates quality systems, and manages FDA and EU notified body interactions so that Linden's portfolio companies can re-enter approval queues without rebuilding internal regulatory teams from scratch.
Is RQM+ a contract research organization for pharma or exclusively medical devices?
RQM+ operates solely within medical devices and in vitro diagnostics. It does not run pharmaceutical clinical trials or compete with full-service CROs like IQVIA or Parexel. Its bench of former FDA device reviewers is a specific asset that has no direct analogue in the pharma services market.
What is RQM+'s known posture on co-investments alongside external GPs?
RQM+ does not co-invest. It is a services platform wholly owned by Linden Capital Partners and deployed as an operational resource inside Linden's portfolio. Allocators evaluating Linden as a GP should understand RQM+ as an internal capability rather than as a standalone investment vehicle.
Does RQM+ maintain philanthropic structures, and how are they separated?
No public record of a philanthropic arm exists. RQM+ operates as a for-profit consultancy with no known foundation, donor-advised fund, or charitable structure associated with the firm or its principals.
Profile maintained by Altss using OSINT (open-source intelligence), regulatory filings, licensed data partners, and verified direct submissions. Read the methodology. Last updated: . Continuous refresh with full update cycles at least every 30 days.
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