Quality Assurance
Audits & Inspection Readiness — From Both Sides of the Table
Internal audits, supplier audits, mock FDA inspections, and audit-readiness from people who get audited monthly.
What It Is
Audits are how quality systems are proven — internal audits, supplier audits, gap audits, certification and MDSAP audits, and FDA inspections. Most medical device manufacturers experience formal external scrutiny only about once a year: an annual ISO 13485 or MDSAP surveillance audit, plus their own internal audit program (and, under EU MDR, an unannounced Notified Body audit only once every several years). That infrequency is exactly why audits cause so much stress — teams rarely practice them.
When You Need It
You need audit support to run your required internal audit program, to qualify and audit suppliers, to prepare for a certification, MDSAP, or Notified Body audit, or to get inspection-ready for an FDA visit. Mock inspections are especially valuable before a PMA pre-approval inspection or a first FDA encounter.
What We Do
We run internal and supplier audits, gap audits against ISO 13485 / QMSR / MDR, and full mock FDA inspections — including front-room and back-room simulation, document pulls, and management interviews. We leave you with a prioritized findings list, CAPA-ready observations, and a coached team that has rehearsed the real thing.
We Live It, Not Just Advise It
Here is what makes us different: Boulder iQ and Boulder Sterilization are FDA-registered establishments, and our customers audit us several times a month. A typical device company sits for roughly one external audit a year. We sit on the other side of the audit table constantly — hosting, answering, and passing client and regulatory audits as the auditee. We know what auditors ask, what good answers sound like, and where teams stumble, because we live both roles. When we prepare you, it is from genuine two-sided experience, not a checklist.
How AuditIQ Helps
AuditIQ analyzes your full QMS documentation at machine speed before an audit, surfacing the gaps, inconsistencies, and missing records an auditor would find — so you fix them first. It turns weeks of manual audit prep into a prioritized punch list.
Learn more about AuditIQ →Frequently Asked Questions
How often does a medical device company get audited?
Most manufacturers face external audits only about once a year — an annual ISO 13485 or MDSAP surveillance audit — plus the internal audits their own QMS requires. Under EU MDR, a Notified Body unannounced audit happens only about once every five years. Because external audits are infrequent, most teams are under-rehearsed when one arrives. We host audits as the auditee several times a month, so we bring that frequency of experience to your preparation.
What is a mock FDA inspection?
A mock inspection simulates an FDA visit end to end: an investigator role-play, front-room/back-room logistics, live document requests, and management interviews. It exposes weaknesses — in records, in answers, in process — while the stakes are still zero, so you fix them before a real 483.
How is Boulder RA/QA different from other audit consultants?
Most audit consultants have only ever sat on the auditor side, or only read about FDA inspections. We do both: we run audits for clients, and as an FDA-registered manufacturing and sterilization operation we are audited by our own customers multiple times a month. We prepare you from real, current, two-sided experience.
Can you help after a 483 or warning letter?
Yes. See our CAPA and remediation service — we move from audit findings into root-cause investigation, corrective action, and the formal response and remediation FDA expects.
Ready to Talk Through Your Audits Project?
Tell us where you are in the process. We respond within one business day.
Request a ConsultThe 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.