ISO 13485 Consulting Services
Quality Resource Center (QRC) provides ISO 13485 consulting services for medical device manufacturers, contract manufacturers, component suppliers, and distributors that need a quality management system a registrar, a notified body, and the FDA will all accept.
We are based in San Jose, in the heart of Silicon Valley, and our ISO 13485 consultants work on-site across the Bay Area and with device organizations nationwide. Our consultants build audit-ready systems around the processes you already run, so compliance does not stop production, engineering, or clinical work.
Call (800) 244-5409 or request a consultation.
Who This Is For
QRC’s ISO 13485 consulting is built for organizations that are:
- Pursuing initial ISO 13485 certification, often on a customer or investor deadline
- Holding ISO 9001 today and now entering the medical device market
- Aligning an existing 21 CFR Part 820 system with the FDA’s Quality Management System Regulation, which incorporates ISO 13485 by reference
- Recovering from registrar nonconformities, a warning letter, or a failed customer audit
- Maintaining a certified system without a full-time quality department
Problems We Solve
Most device companies do not fail an audit because they lack good engineering. They fail because the evidence is not there when the auditor asks for it. The gaps we are called in to close are consistent:
- Design controls. Design inputs, outputs, reviews, verification, validation, transfer, and change control that trace end to end through a design history file.
- Risk management. A working ISO 14971 risk process connected to design and process FMEAs, production controls, and post-market feedback — not a spreadsheet written the week before the audit.
- CAPA. Corrective and preventive action with real root cause analysis, effectiveness checks, and closure discipline, linked to complaints and nonconforming product.
- Supplier controls. Supplier qualification, evaluation, monitoring, purchasing data, and quality agreements that hold up when your critical processes sit outside your building.
- Process validation. Validation of production and sterilization processes, software used in the quality system, and the records that prove ongoing control.
- Traceability and records. Unique device identification, lot and serial traceability, document control, and retention that matches product lifetime.
ISO 13485 Consulting and Implementation Services
QRC delivers end-to-end ISO 13485 consulting aligned with medical device regulatory and quality requirements.
- Turnkey quality management system design and implementation
- Gap analysis against ISO 13485 and applicable FDA requirements
- Project and program management support
- Policy, procedure, and work instruction development
- Design control and design history file build-out
- Risk management, including design and process FMEA
- CAPA, complaint handling, and post-market feedback systems
- Supplier qualification and supplier audit programs
- Process and product verification and validation
- Product identification and traceability
- Firmware and software management controls
- Support for implantable medical devices
- Outsourced internal audits and registrar audit preparation
- ISO 13485 internal auditor training and certification
- Management representative training
- Key performance indicator (KPI) development
Need classroom or onsite instruction rather than an implementation project? See our ISO 13485 training modules. Organizations certifying a mixed portfolio often pair this work with ISO 9001 consulting, and our practical guide to ISO 13485 explains how the two standards differ. For a short primer on the standard itself, see ISO 13485: standards for medical devices.
How an Engagement Works
- Consultation. A no-cost conversation about your devices, markets, timeline, and current system.
- Gap assessment. We audit what exists against ISO 13485 and the regulatory requirements that apply to you, then report what is missing and what it will take.
- Implementation plan. A scoped schedule with owners, milestones, and a realistic certification date.
- System build. We develop the documentation with your team, embed design controls, risk management, CAPA, and supplier controls into the way you already work, and train the people who will run it.
- Internal audit and management review. A full internal audit cycle and a facilitated management review so the system has a record before the registrar arrives.
- Certification audit support. Registrar liaison, readiness review, and on-site support through stage 1 and stage 2.
- Ongoing maintenance. Surveillance audit preparation, internal audits, and system updates as your products and regulations change.
What You End Up With
A certified, working ISO 13485 quality management system your team can operate without a consultant in the building: documented design controls, a live risk file, a CAPA process that closes, qualified suppliers, and audit evidence that is ready before the auditor asks for it.
Why Medical Device Companies Choose QRC
- Since 1992. QRC has designed and implemented quality management systems for more than 1,000 organizations across regulated industries. See our corporate profile.
- Minimal operational disruption. Compliance has to be achieved without interrupting production, engineering, or clinical activities.
- First-time certification success. Organizations using QRC’s full-service ISO 13485 consulting program consistently achieve certification on their initial registrar audit.
- Cost-effective. Device companies frequently report that QRC’s consulting costs are significantly lower than the internal resources required to design, implement, and maintain an ISO 13485–compliant system.
Executive Perspective
Mark Bringolf, CEO, Platinum Imaging:
“Dan and the QRC team did an excellent job steering us through the ISO certification process. We achieved ISO 13485 as well as ISO 9001 in approximately nine months. Great follow-up and communication throughout the process.”
Speak With an ISO 13485 Consultant
Tell us what you make and when you need to be certified, and we will tell you what the project actually looks like.
Call (800) 244-5409 — local (408) 371-9995 — or request a consultation.