Quality Assurance
ISO 13485 Quality Management System
Build, implement, and maintain a lean, audit-ready quality system.
What It Is
ISO 13485 is the international quality management system standard for medical devices, and the backbone of regulatory compliance worldwide — it underpins EU MDR/IVDR conformity, MDSAP, and (through the FDA QMSR) U.S. requirements. A compliant QMS covers design controls, document and record control, risk management, supplier controls, CAPA, production and process controls, and management responsibility, scaled to your device and company size.
When You Need It
You need ISO 13485 support when standing up a quality system for the first time, when scaling a startup system toward certification, when preparing for a certification or MDSAP audit, or when your existing system has drifted and needs remediation. Building it right and lean the first time is far cheaper than retrofitting a bloated system later.
What We Do
We start with a gap assessment, define the right scope for your stage, and build a lean QMS — procedures, work instructions, templates, and records — that your team can actually run. We recommend and implement the right eQMS platform, transfer documentation, train your people, and support you through certification. For early-stage companies we phase the build so your quality system grows with your product rather than ahead of it.
We Live It, Not Just Advise It
We do not hand you procedures we have never used. The Boulder BioMed family runs its own ISO 13485 quality system every day across manufacturing, sterilization, and testing. The design controls, CAPA, and supplier procedures we build for you are the same kinds we operate and get audited on ourselves — written to survive a real audit, not just to look complete.
How AuditIQ Helps
AuditIQ accelerates QMS work by reviewing your documentation set against ISO 13485 and the FDA QMSR, identifying missing or inconsistent procedures and prioritizing what to fix before a certification or surveillance audit.
Learn more about AuditIQ →Frequently Asked Questions
How long does it take to implement ISO 13485?
For a small device company, a lean ISO 13485 system is typically built and implemented over roughly 3 to 6 months, followed by a period of records generation before a certification audit. Timing depends on your device complexity, team bandwidth, and whether you are building fresh or remediating.
Do I need ISO 13485 certification for the U.S. market?
FDA does not require ISO 13485 certification, but the FDA QMSR (effective 2026) harmonizes U.S. quality system requirements with ISO 13485, so a 13485-based system now satisfies both. Certification is required or strongly expected for the EU and MDSAP markets.
Which eQMS platform should I use?
It depends on your size, budget, and submission timeline. We are platform-independent and have implemented systems across the common medical device eQMS tools; we recommend based on your needs rather than a referral relationship.
Ready to Talk Through Your ISO 13485 QMS 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.