Medical Device Sourcing and Compliance: Navigating Regulatory Requirements
Dr. Patricia Wong
Published on 2024-05-20
Understanding the complex regulatory landscape for medical device sourcing, from FDA requirements to ISO standards and quality systems.
Medical device sourcing requires strict adherence to regulatory requirements, quality standards, and documentation procedures to ensure patient safety and market access.
Regulatory Framework Understanding
Navigating FDA 510(k), CE marking, ISO 13485, and other regulatory requirements that impact sourcing decisions and supplier selection.
Supplier Qualification and Auditing
Comprehensive supplier evaluation processes including quality system assessments, facility audits, and ongoing monitoring.
Design Controls and Documentation
Implementing design controls, risk management, and documentation requirements throughout the sourcing and development process.
Supply Chain Traceability
Establishing complete traceability systems for materials, components, and processes to support regulatory compliance and recall procedures.
