This template is designed to guide manufacturers in establishing, documenting, and maintaining a comprehensive Design File for medical devices. It serves as a central repository for all design and development activities, ensuring traceability, regulatory compliance, and effective control throughout the product lifecycle.
Within this template, manufacturers can systematically document the entire design and development process from initial concept and planning through design transfer and post-market considerations. It establishes a clear and traceable linkage between design inputs, design outputs, verification, validation, and risk management activities, ensuring that all applicable safety and performance requirements are consistently met.
Furthermore, this template supports robust design traceability through structured tools such as the Design Traceability Matrix (DTM), enabling clear linkage between user needs, intended use, regulatory requirements, and verification and validation outcomes.
Developed by experienced professionals, this template enables medical device manufacturers to maintain a well-structured, audit-ready Design File aligned with the requirements of MDSAP, ISO 13485, MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746) thereby supporting product safety, performance, and global regulatory compliance.
Price: $650
