Quality Assurance
Lean, audit-ready quality systems — built and maintained by people who run an FDA-registered operation and get audited from both sides every month. ISO 13485, the FDA QMSR transition, audits and mock inspections, CAPA and remediation, and software validation.
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.
The QMSR clock is running.
FDA’s Quality Management System Regulation takes effect February 2, 2026, harmonizing 21 CFR 820 with ISO 13485. Whether you are certified or on a legacy QSR system, we can run your gap assessment and transition.
QMSR Transition →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.