ISO 13485 Medical Device Quality Management Consulting
ISO 13485:2016 · Medical Devices Quality Management
For medical device manufacturers, component suppliers and contract manufacturers that need a certified quality management system. We assess gaps against ISO 13485:2016, document design and production controls, set up risk management and CAPA, run the internal audit and prepare you for certification.
Reviewed by Santhosh K, Principal GRC Advisor, CyberWave GRC · CISA, CISM, CCISO, HITRUST CCSFP, CHQP, ISO/IEC 27001 Lead Auditor
What is ISO 13485:2016?
ISO 13485 specifies requirements for a quality management system for organizations involved in the design, production, installation, and servicing of medical devices, ensuring regulatory compliance and patient safety.
Key Focus Areas
What our engagement includes
How the engagement works
Gap Analysis
Assess current quality practices against ISO 13485 requirements.
QMS Design
Design a quality management system for medical device lifecycle.
Risk Management
Implement ISO 14971 risk management processes.
Documentation
Develop technical files, DHF, and DMR documentation.
Certification Support
Guide through notified body audits and certification.
Timeline and cost factors
Typical timeline: 4–9 months for implementation and certification. Cost depends on scope, organization size, number of locations and systems, current maturity and how much hands-on implementation support you need. Any certification, assessment or audit body fees are separate and set by that body.
Questions buyers ask
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Speak with our experts about consulting, implementation, and audit support for Medical Devices Quality Management.