ISO 13485 Consulting

Gap Assessments and QMS Builds

Whether you have a quality system that needs to meet the standard or you are building one from scratch, we start the same way: a clause-by-clause gap assessment against ISO 13485:2016. From there we design and implement what is missing, from document control and design controls to supplier management and CAPA, tailored to your products and your production environment. We stay through implementation, train your staff, and make sure every system we build works in practice on your floor.

• Clause-by-clause ISO 13485 gap assessments
• Full QMS design and implementation
• Design controls and technical documentation
• CAPA, supplier controls, and internal audit programs

ISO 14971 Risk Management

ISO 13485 leans on risk-based thinking everywhere, and ISO 14971 is the standard that defines how device risk management actually works. We build and remediate risk management files, from hazard identification and risk estimation through risk controls, benefit-risk analysis, and post-production monitoring, so your risk documentation stands up in certification audits and FDA inspections alike.

• Risk management plans and files per ISO 14971
• Hazard analysis and risk estimation
• Risk controls and effectiveness verification
• Post-production risk monitoring processes

Certification Audit Preparation and QMSR Alignment

Pursuing certification for international markets or customer requirements? We prepare your facility and your team for the certification audit: pre-audit readiness assessments, documentation preparation, staff training, and guidance through the audit itself, the same way we support GMP certification schemes. And because FDA's QMSR now incorporates ISO 13485 by reference, this work does double duty. One well-built system covers your registrar and your regulator. For the FDA side of that story, see our 21 CFR 820 and QMSR consulting, or browse all of our services.

• Pre-audit readiness assessments
• Documentation preparation and review
• Staff training and interview preparation
• QMSR and ISO 13485 alignment in one QMS

ISO 13485 Questions

What is the difference between ISO 13485 and ISO 9001?

ISO 9001 is the general-purpose quality management standard used across industries. ISO 13485 is tailored specifically to medical devices, with stronger emphasis on regulatory requirements, risk management, and process validation. Device companies certify to ISO 13485 because regulators and customers in the device world expect it, and FDA's QMSR now incorporates it by reference.

What is ISO 13485?

ISO 13485:2016 is the international standard for quality management systems in the medical device industry. It covers the full device life cycle, from design and development through production, distribution, and servicing, with a strong emphasis on risk management and regulatory requirements.

How does ISO 13485 relate to FDA's QMSR?

As of February 2, 2026, FDA's Quality Management System Regulation (21 CFR Part 820) incorporates ISO 13485:2016 by reference. A quality system built properly to the standard now forms the core of FDA compliance, with a small set of FDA-specific additions on top.

What is ISO 14971?

The international standard for medical device risk management. It defines the process for identifying hazards, estimating and evaluating risks, implementing controls, and monitoring effectiveness across the device life cycle. ISO 13485 relies on this process, so the two standards work together.

How long does certification preparation take?

It depends on where your system stands today. A company with a solid QMS may be audit-ready in a few months, while building from scratch takes longer. We start with a gap assessment, then set a realistic plan to audit readiness.