This template package is designed to guide medical device manufacturers in establishing, documenting, and maintaining all essential quality procedures, records, and controlled formats required under ISO 13485 and FDA Quality Management System Regulation (QMSR) requirements under 21 CFR Part 820. It serves as a comprehensive framework for implementing and maintaining an effective Quality Management System (QMS) aligned with global medical device regulatory requirements.
The package includes standardized procedures, formats, and records covering key QMS processes such as document and record control, design and development, supplier management, purchasing controls, production and process controls, labeling and packaging controls, complaint handling, CAPA, internal audits, training management, traceability, risk management, post-market surveillance, servicing activities, change control, and management review.
By integrating these procedures into operational and regulatory activities, manufacturers can establish controlled and consistent processes that support product quality, patient safety, regulatory compliance, and inspection readiness. The template package also supports traceable documentation practices, effective process control, and continual improvement activities throughout the medical device lifecycle.
In addition, the package supports FDA-specific quality management system requirements, including complaint records, UDI traceability, labeling and packaging controls, servicing records, supplier controls, and regulatory reporting obligations under QMSR requirements.
Developed by experienced medical device quality and regulatory professionals, this template package serves as a practical and reliable solution for medical device companies seeking to implement a compliant, audit-ready, and well-documented Quality Management System aligned with ISO 13485:2016 and FDA QMSR requirements.
Price: $650
