Medical device compliance consultant for Boston-area startups.
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- ASQ CMQ/OE
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- Securiti AI Governance
Greater Boston has one of the densest concentrations of medical device innovation in the world. From Kendall Square software startups to the Route 128 hardware corridor, from Worcester biomanufacturing to the device groups embedded in Mass General Brigham and Boston Children’s — the regional ecosystem produces more medical device companies per capita than almost anywhere else.
What that ecosystem doesn’t have enough of: regulatory and quality consultants who work the way startups actually need them to. Fixed prices instead of hourly billing. Practical scope instead of enterprise-style engagements. Speed instead of process-for-process’s-sake.
We work with seed-stage and Series A medical device companies across the Boston metro area on ISO 13485 audits, FDA regulatory strategy, Quality Management systems, and Information Security. Remote-first, with on-site availability when it matters.
For Boston-area founders.
ISO 13485 Audits
Fixed-price internal audits and certification readiness assessments. We’re often engaged before BSI, TÜV, or other notified bodies arrive for a stage audit.
Explore audit services →FDA Regulatory Strategy
510(k), 513(g), De Novo, pre-submission strategy. We’ve helped startups identify pathways that saved $100,000s and 12+ months versus their original assumptions.
Read our guide →Quality Management Systems
ISO 13485:2016 and FDA QMSR-aligned QMS implementation for early-stage companies. Built to be lived in, not just to pass an audit.
Learn more →Local context, senior judgment.
We understand the local landscape.
Boston’s medical device ecosystem has specific rhythms: MIT and Harvard tech transfer cycles, the MassChallenge HealthTech accelerator, the academic medical center spinout pattern, MassMEDIC’s industry events, the LabCentral graduate trajectory. Working with founders who navigate this landscape means understanding it ourselves.
We work with the registrars who audit here.
BSI Group has a strong Boston presence; TÜV, Smithers, and other major notified bodies audit Massachusetts companies regularly. We prepare clients specifically for the auditor styles and expectations of each registrar.
We’re available in person when it matters.
Most of our audit and consulting work is remote — faster for everyone, less expensive, and ISO 13485 explicitly permits it. But we’re based in the area and can be on-site for stage audits, FDA inspections, or kickoff meetings when it makes the difference.
We’ve been on the other side of the table.
Two decades of medical device experience means we’ve sat in seats from QA Manager to Director of Regulatory to Managing Director of consulting. We know what FDA reviewers look for, what notified body auditors press on, and what investors want to hear about regulatory risk.
Engagement formats.
Productized services
Internal Audits ($3,500) and Certification Readiness Assessments ($7,000) at fixed prices with defined timelines. Best for companies with a specific, scoped need.
Retainer
Monthly or quarterly retainers for ongoing QMS, regulatory, and audit support. Best for growing companies that want a fractional regulatory function without hiring full-time.
Project-based
Defined-scope engagements for specific submissions, audits, or implementations. Pricing varies with scope.
Initial scoping calls are free.
Common questions.
What areas in Massachusetts do you serve?
We serve Greater Boston, Cambridge, and the broader Massachusetts medical device community — including Waltham, Burlington, Lexington, Newton, Woburn, Worcester, and surrounding areas. Most engagements are remote regardless of location, but we’re available on-site within roughly an hour of Boston when needed.
Do you work with companies outside Massachusetts?
Yes. While we focus on the Boston-area medical device ecosystem, we serve clients across the United States and internationally — past and current engagements have included companies in Canada, the United Kingdom, Germany, Spain, Sweden, Norway, China, Australia, and Argentina. Remote engagement is standard, and we routinely work across time zones. The Boston focus reflects where we’re embedded and where on-site work happens most easily — not a limit on geography.
How quickly can you start an engagement?
For our productized services (ISO 13485 Internal Audits and Certification Readiness Assessments), we typically start within 1–2 weeks of contract signing. Expedited engagements with faster turnaround are available at a 50% premium, subject to capacity. For project-based or retainer work, lead time depends on scope — usually 2–4 weeks.
Which notified bodies do you have experience preparing clients for?
We have direct experience preparing clients for audits by BSI Group, TÜV, Smithers, and other major notified bodies and registrars. Each has its own auditor style and emphasis, and we prepare clients specifically for who’s coming. If your registrar isn’t named here, ask — we likely have relevant experience or can quickly come up to speed on their approach.
What stage of medical device startup do you typically work with?
Most of our work is with seed-stage through Series B medical device companies. Pre-seed founders often engage us for early regulatory analysis (the highest-leverage investment of the first year), seed-stage companies for QMS foundations and initial submissions, and Series A/B companies for scaling their quality and regulatory functions. We’re less suited to large enterprises with mature compliance teams — our model is built for companies that need senior judgment at startup pricing.
Do you work with digital health and medical device software companies?
Yes. A significant portion of our work involves software-driven medical devices, digital therapeutics, AI/ML-enabled devices, and clinical decision support tools. The regulatory landscape for these categories has evolved rapidly — the 21st Century Cures Act CDS exclusion, FDA’s guidance on AI/ML-enabled device software functions, and the FDA QMSR transition all affect how digital health companies should structure their compliance from day one. We help startups think through whether their product is even a device, and if so, what the lightest viable pathway is.
Why does your practice combine quality, regulatory, and information security?
These functions have traditionally been separate disciplines with separate consultants — but for a modern medical device startup, especially in software-driven categories, they’re deeply intertwined. FDA expects cybersecurity controls in 510(k) submissions. ISO 13485 and ISO 27001 share significant overlap. Information security incidents have quality implications and vice versa. We integrate these three functions deliberately so startups don’t have to coordinate three different consultants on related problems.
Can you support companies at MassChallenge HealthTech, LabCentral, or other Boston accelerators?
Yes. We’re happy to work with early-stage companies in accelerator programs and often engage at the stage where founders are just starting to think seriously about regulatory strategy. Smaller scoping engagements (regulatory analysis, lightweight audits) often fit accelerator budgets better than full QMS implementations.
Do you work with academic medical center spinouts?
Boston has one of the densest concentrations of academic medical center research in the country — MGH, Brigham and Women’s, Boston Children’s, Dana-Farber, the MIT and Harvard ecosystems, and others continuously produce device-related spinouts. These spinouts often face specific regulatory considerations: IP and data provenance from the parent institution, clinical evidence developed pre-formation, tech transfer office requirements, and timing pressure around grant funding cycles. We’re set up to support these companies and would welcome a conversation about whether we’re the right fit.
How do we get started?
The fastest path is a 30-minute scoping call. We use it to understand what you’re building, what stage you’re at, what regulatory or quality questions are on your near-term horizon, and whether our services are actually the right fit. There’s no cost or obligation.
Let’s talk about your roadmap.
Whether you’re preparing for your first notified body audit, navigating a 510(k) decision, or building your QMS from scratch — we’d be glad to talk.
Schedule a scoping call ↗