Frequently Asked Questions
The questions device and IVD teams ask us most about regulatory strategy, quality systems, audits, and how we work.
What does Boulder RA/QA do?
Boulder RA/QA provides regulatory affairs and quality assurance consulting for medical device and IVD companies. On the regulatory side we handle FDA submissions (510(k), De Novo, PMA, Pre-Sub, 513(g)) and EU MDR/IVDR. On the quality side we build and remediate ISO 13485 quality systems, run audits and mock FDA inspections, manage CAPA and 483/Warning Letter remediation, support the FDA QMSR transition, and handle software validation. We also offer clinical trial strategy and AuditIQ, our AI-assisted audit tool.
What makes Boulder RA/QA different from other regulatory and quality consultants?
Two things. First, we live it: we are part of the Boulder BioMed family, an FDA-registered operation that manufactures, sterilizes, and tests medical devices in-house every day. Everything we do for clients, we already do for ourselves — so our advice is grounded in operations, not theory. Second, we know audits from both sides: as an FDA-registered facility, our own customers audit us several times a month, while a typical device company faces external audits only about once a year. We sit on both sides of the audit table constantly.
How often does a medical device company actually get audited?
Most manufacturers face external audits only about once per year — an annual ISO 13485 or MDSAP surveillance audit — plus the internal audits their own quality system requires. Under EU MDR, a Notified Body conducts an unannounced audit only about once every five years. Because external audits are infrequent, most teams are under-rehearsed when one happens. Boulder RA/QA hosts client audits of our own operation several times a month, so we bring that frequency of real experience to your audit preparation.
What is AuditIQ?
AuditIQ is Boulder RA/QA’s AI-assisted audit and compliance tool. It reviews quality management system documentation at machine speed, surfaces gaps against FDA QSR/QMSR and ISO 13485, and accelerates audit preparation and remediation. It reflects our commitment to leading on AI integration in medical device quality — while keeping experienced human regulatory professionals in the loop on every engagement.
Which FDA pathway does my device need — 510(k), De Novo, or PMA?
It depends on risk and whether a predicate exists. Most Class II devices with a suitable predicate use a 510(k). Novel low-to-moderate-risk devices with no predicate use De Novo. High-risk Class III devices use PMA, usually with clinical data. If your classification is unclear, a 513(g) or a Pre-Submission resolves it before you commit to a strategy. We help you make this call early so you do not build on a wrong assumption.
Do you handle the testing my submission needs, or just the paperwork?
Both — and integrating them is our advantage. The sterilization validation, EO/CD residuals, microbiology, package and shelf-life validation, and engineering data that submissions require are produced inside the Boulder BioMed family (Boulder Sterilization, Boulder BioLabs, Boulder Package Testing, Boulder iQ). We coordinate the testing and author the submission as one connected program.
When does the FDA QMSR take effect, and what do I need to do?
The FDA Quality Management System Regulation (QMSR) takes effect February 2, 2026, harmonizing 21 CFR 820 with ISO 13485:2016. If you run a legacy QSR-only system you need a full transition; if you are already ISO 13485 certified you mainly need to reconcile the FDA-specific requirements QMSR retains. We run the gap assessment and the transition either way.
Can you help a startup that has nothing in place yet?
Yes. Early-stage companies are a core focus. We phase the build so your quality system and regulatory strategy grow with your product rather than ahead of it — a lean ISO 13485 system, the right first FDA interaction (often a Pre-Sub), and a testing plan scoped to what your stage actually needs.
Where are you located, and do you work with companies outside Colorado?
We are based in Boulder, Colorado, and we work with medical device and IVD companies across the United States and internationally. Much of regulatory and quality work is done remotely, and our in-house testing operations serve clients nationwide.
How do I get started?
Request a consult through our contact form or call 303-531-1238. Tell us about your device and where you are in the process. We respond within one business day with a clear view of your pathway and the next concrete step.
Still Have Questions?
Our team is ready to discuss your regulatory pathway or quality system.