ISO 13485 Consulting Services
Quality Resource Center (QRC) provides ISO 13485 consulting services for medical device manufacturers and related service providers seeking certification, regulatory alignment, and operational control.
QRC has supported medical device organizations for over a decade, helping them implement audit-ready quality management systems that meet ISO 13485, FDA, and customer requirements.
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.”
ISO 13485 Consulting for Medical Device Organizations
ISO 13485 is the international quality management system standard for medical devices, focused on regulatory compliance, risk management, and product safety throughout the product lifecycle.
QRC’s ISO 13485 consultants work alongside your team to implement systems that meet certification and regulatory expectations while allowing your organization to continue day-to-day operations with minimal disruption.
Why Medical Device Companies Choose QRC
- Minimal operational disruption. Our consultants recognize that regulatory compliance must 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.
- Medical device expertise. QRC understands regulatory expectations, risk-based controls, and lifecycle documentation requirements.
This consistent record of success is what separates QRC from template-driven or generalist consulting providers.
ISO 13485 Consulting & Implementation Services
QRC delivers end-to-end ISO 13485 consulting services aligned with medical device regulatory and quality requirements.
- Turnkey quality management system design
- Project and program management support
- Outsourced internal audits
- ISO 13485 internal auditor training and certification
- Management representative training
- Process identification and interaction mapping
- Policy and procedure development
- Key performance indicator (KPI) development
- 21 CFR compliance support
- Support for implantable medical devices
- Firmware and software management controls
- Risk management, including design and process FMEA
- Product identification and traceability
- Process and product verification and validation
Cost-Effective ISO 13485 Consulting
Medical 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 quality management system.
Speak With an ISO 13485 Expert
Contact (800) 244-5409
Local: (408) 371-9995
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