Quality Assurance (QA) Assistance
RDEC helps you establish and maintain a robust quality management system (QMS) to meet the latest FDA regulations and international standards. Whether setting up a new QMS or optimizing an existing one, our experts ensure compliance and operational excellence.
- Quality System Setup: We help you establish a robust quality management system (QMS) tailored to your specific needs, ensuring compliance with the latest FDA regulations and ISO standards, including ISO 13485.
- FDA Requirements: Our team provides expert guidance on meeting the stringent quality requirements of the FDA, helping you navigate the complexities of 21 CFR Part 820 and other relevant regulations.
- Internal Audits and Compliance: We conduct thorough internal audits to ensure your quality system is fully compliant, identifying areas for improvement and ensuring that all processes meet regulatory expectations.
- Document Control: Assistance with setting up effective document control systems to manage all critical documentation, including Design History Files (DHF), Device Master Records (DMR), and standard operating procedures (SOPs).
- Supplier Quality Management: We help you develop and manage supplier quality agreements, ensuring that all third-party vendors meet the necessary quality standards for medical device production.
- Risk Management: We provide risk management support in accordance with ISO 14971, identifying potential risks throughout the product lifecycle and implementing mitigation strategies to minimize disruptions and ensure product safety and compliance.