Build a medical-device quality system that satisfies ISO 13485, aligns with FDA and EU expectations, and holds up under a Notified Body or FDA inspection.
Book a consultation All servicesISO 13485 is the quality management system standard for organizations that design and manufacture medical devices. It emphasizes regulatory alignment, risk management, design controls, traceability, and process validation across the product lifecycle.
For most device and diagnostics companies, an ISO 13485 QMS is the backbone that also carries FDA 21 CFR 820 (Quality System Regulation), EU MDR/IVDR, and ISO 14971 risk-management obligations — so it needs to be built with all of them in view.
We build or fix an ISO 13485 QMS — design controls, document control, CAPA, supplier controls, and complaint handling.
We harmonize ISO 13485 with FDA 21 CFR 820, EU MDR/IVDR, and applicable regional requirements so you maintain one system, not five.
We stand up a risk-management file and process that auditors and reviewers accept.
We prepare you for Notified Body audits and FDA inspections with mock audits and evidence trails.
Yes. We help medical-device and diagnostics companies build and maintain ISO 13485 quality systems, align with FDA 21 CFR 820 and EU MDR/IVDR, and apply ISO 14971 risk management.
No, but they overlap heavily. ISO 13485 is an international QMS standard; FDA 21 CFR 820 is US regulation. A well-built ISO 13485 system can be structured to satisfy both, which is how we recommend building it.
Risk management to ISO 14971 is expected for medical devices and is referenced throughout the regulations. We typically build the ISO 13485 QMS and ISO 14971 risk process together.
Yes — building it right the first time is far cheaper than remediating later. We right-size an early-stage system that can scale with you toward clearance or CE marking.
Led by a quality executive with a Ph.D., an MBA, and Six Sigma Black Belt (CSSBB) credentials and 15+ years across diagnostics, medical devices, food safety, and manufacturing.
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