10.07.18 Frankfurt, GERMANY – Cyntegrity today announced the worldwide release of their Medical Device RACT, “MD-RACT”, the world’s first Risk Assessment and Categorization Tool for clinical investigations, that combines the best practices in Life Sciences with subject matter expertise in Medical Devices bringing MedTech manufacturers, innovators and regulators the next level in cloud-based Risk-based Quality Management (RBQM) services.
“Medical device manufacturers are now similarly to pharma challenged to transform their traditional risk management strategies into actions and decisions that cover the complete product life-cycle.”, said Dr. Artem Andrianov, CEO Cyntegrity.
“We observe medical device companies struggling with a greater potential for error. The continuous need for clinical evidence, the increasing complexity of new medical devices, and the size and global nature of the clinical investigations is keeping them awake at night. Our intelligent RBQM services enable MedTech companies to better understand, manage and mitigate the growing uncertainties.”
Pre and Post-Market Risks in Focus
“Today’s regulations regard risk management and clinical evaluation as interdependent processes, calling for careful alignment of the risk management system with the clinical evaluation. Our Risk-based Quality Management cloud services could cover the entire regulatory footprint.”, said Linda Bunschoten, Global Director of Marketing Cyntegrity.
Collaborative Risk Management in the Cloud
MD-RACT is designed for MedTech teams helping them speed up and optimize the risk identification and assessment process. The proprietary MD-RACT library is an enhanced subset of the, in Life Sciences, widely accepted TransCelerate RACT.
MD-RACT is specifically tailored to effectively de-risk medical device trials conducted by small and mid-sized medical device companies and CROs and is therefore fully ISO 14155:2011 and EU MDR compliant.
Cyntegrity has been developing proprietary cloud-based RBQM solutions for the Life Sciences industry since 2013. Cyntegrity’s mission is to offer high-quality risk management analytics that are more predictive than retrospective, and that can integrate knowledge from previous investigations with contextual, real-world data protecting human subjects, ensuring regulatory compliance and ensuring data integrity.