At Advance Medical, we understand that software validation can seem incredibly complex. That’s why we’ve designed a comprehensive Software Validation Protocol to simplify the process and ensure compliance with industry standards. In collaboration with our quality team from EFFETRE, we have developed a new service for helping our clients through the software validation procedures.
ENHANCING COMPLIANCE AND QUALITY
Software validation can often seem daunting and is frequently delayed because of its complexity. With MDR continuing as a primary focus, regulatory bodies are now emphasizing the importance of software validation. Our FocalPoints Software Validation Protocol adheres to ISO 13485:2016 standard, ensuring compliance with internationally recognized guidelines for medical device software, and offering a customized consulting service developed in partnership with our QA team.
The validation process begins with a tailored Validation Protocol that defines strategy, risk analysis, and software requirements, ensuring alignment with regulatory standards and user needs. Core steps include Installation Qualification (IQ) to verify setup, Operational Qualification (OQ) to test functionality, and Performance Qualification (PQ) to confirm reliable performance. Concluding with a Validation Report, the protocol documents compliance thoroughly.
WHO SHOULD DO THE SW VALIDATION?
The manufacturer is responsible for validation as referenced in the quality standards of ISO 13485 and in the GMPs in use for the production of medical devices. The software validation should be based on a thorough Risk Analysis where the software has an impact on the Quality Management System processes. Our Software Validation Protocol supports manufacturers in fulfilling this responsibility, providing a structured approach that aligns with industry best practices and regulatory demands.
COMPLETE AND TESTED PROTOCOL
CHECKLISTS FOR THE IQ, OQ, PQ
SUPPORT OF TOP EXTERNAL CONSULTANTS
WHY CHOOSE OUR SW VALIDATION SERVICE?
Our FocalPoints Software Validation Protocol offers a holistic, step-by-step approach, supported by documentation and video tutorials, to streamline validation and reduce risks specific to contact lens manufacturing, helping labs avoid costly errors.
COMPREHENSIVE TRAINING MATERIAL
Successful software validation depends on clear, practical guidance. Our detailed documentation and video tutorials align closely with the training materials, providing users with the tools and confidence needed to execute the process smoothly and effectively
EXPERT VALIDATION CONSULTANTS
EFFETRE, our trusted external consultant and partner, brings unparalleled expertise in software validation, providing invaluable assistance throughout the process. EFFETRE was founded with the aim of pursuing the development of services related to research, engineering and industrialisation of products, systems and technologies in the field of Medical Device. The company operates internationally since 1987 by offering specialised services of quality certification and validation.
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EFFETRE SRL was founded with the aim of developing services related to research, engineering and industrialisation of products, systems and technologies in the field of Medical Devices. The company operates internationally since 1987 by offering services of quality certification and validation.