Everything we do for you, we already do for ourselves.
Most regulatory and quality consultants advise from the outside. We don’t. Boulder RA/QA is part of an FDA-registered operation that designs, manufactures, sterilizes, packages, and tests medical devices every single day. The submissions we write are backed by data our own family generates. The quality systems we build are the same kind we run and get inspected on. We are not talking heads in a basement — we live the requirements we help you meet.
We design & manufacture
Boulder iQ engineers and builds devices under design controls — so we know what your DHF actually needs.
We sterilize
Boulder Sterilization runs EO and chlorine dioxide cycles — so we understand your sterilization validation from the inside.
We test
Boulder BioLabs runs sterility, bioburden, and residuals; Boulder Package Testing runs ISO 11607 — your submission data, in the family.
We get inspected
As FDA-registered establishments, we sit for audits constantly — we prepare you from real, current experience.
Regulatory Affairs
From classification to clearance — U.S. and international.
FDA 510(k)
Predicate strategy, testing plans, and eSTAR-format 510(k) submissions that clear the first time.
De Novo
De Novo strategy and submission for novel Class I/II devices that have no valid predicate.
PMA
PMA strategy, module support, and clinical evidence coordination for Class III devices.
Pre-Sub / Q-Sub
Pre-Submission strategy and Q-Sub meeting support to de-risk your pathway with FDA early.
513(g)
When your classification or pathway is genuinely unclear, a 513(g) gets FDA’s formal read.
EU MDR / IVDR
Technical documentation, CER/PER, and Notified Body strategy for EU MDR and IVDR.
Quality Assurance
Lean, audit-ready quality systems — built by people who run one.
ISO 13485 QMS
QMS gap assessment, build, eQMS implementation, and ongoing maintenance to ISO 13485.
Audits
Internal, supplier, and gap audits plus mock FDA inspection readiness — by a team audited from both sides.
QMSR Transition
Gap assessment and transition to FDA’s QMSR, which harmonizes 21 CFR 820 with ISO 13485.
CAPA & Remediation
CAPA systems plus FDA Form 483 and Warning Letter response and remediation.
Software Validation
SaMD regulatory strategy, software V&V documentation, and CSV for quality-system tools.
Our Signature Advantage
We know the audit table from both chairs.
A typical medical device company sits for one external audit a year — an annual ISO 13485 or MDSAP surveillance visit — plus their internal audits. Under EU MDR, a Notified Body shows up unannounced only once every five years. External audits are rare, which is exactly why they cause so much stress.
We are different. As FDA-registered establishments, our own customers audit us several times a month. We sit in the auditee’s chair constantly — answering, defending, and passing. When we prepare you for an inspection, it is from genuine, current, two-sided experience.
Explore Audit & Inspection ReadinessLeading on AI Integration
Meet AuditIQ.
AuditIQ is our AI-assisted audit and compliance tool. It reviews your entire quality management system at machine speed, surfaces gaps against FDA QSR/QMSR and ISO 13485, and turns weeks of manual audit prep into a prioritized punch list. It is how a medical device company puts modern AI to work on real compliance problems — with experienced humans in the loop on every call.
AI is a powerful part of what we do — but it is not all we are. AuditIQ amplifies a full-service regulatory and quality team; it does not replace the judgment that gets devices cleared.
Explore AuditIQFrom Concept to Clearance
One connected program — regulatory strategy, the quality system, and the testing to back it, under one roof.
Classification & Pathway
Confirm device class and the right route — 510(k), De Novo, PMA — with a 513(g) if classification is unclear.
Pre-Submission Alignment
Lock your predicate and testing plan with FDA before you spend on testing, via a focused Q-Sub.
Quality System & Design Controls
Stand up or remediate a lean ISO 13485 / QMSR-ready QMS and the design history file your submission needs.
Testing — In the Family
Sterilization, residuals, microbiology, and package validation generated by Boulder iQ, Sterilization, BioLabs, and Package Testing.
Submission
Author and compile the eSTAR submission — complete and consistent before it leaves our hands.
Clearance & Post-Market
Manage FDA interactions through clearance, then audits, CAPA, and post-market surveillance to keep you compliant.
The Boulder BioMed Family
One campus, one quality system. We manufacture, sterilize, and test medical devices in-house — so our regulatory and quality work is grounded in operations, not theory.
Frequently Asked Questions
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, 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.
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 internal audits. Under EU MDR, a Notified Body conducts an unannounced audit only about once every five years. We host client audits of our own operation several times a month, so we bring that frequency of experience to your 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 — reflecting our commitment to leading on AI integration in medical device quality.
Do you handle the testing my submission needs, or just the paperwork?
Both. The sterilization validation, residuals, microbiology, package and shelf-life testing, and engineering data that submissions require are produced inside the Boulder BioMed family. We coordinate the testing and author the submission as one connected program.
When does the FDA QMSR take effect?
February 2, 2026. The QMSR harmonizes 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 either way.
Request a Consult
Tell us about your device and where you are in the process. We respond within one business day.