Elevate medical device management with our software solutions. Streamline processes, ensure compliance, and enhance overall operational efficiency.
Medical device standardsMedical device software traceabilityMedical device software process assessment and improvementSoftware traceability is central to medical device software development and essential for regulatory approval. In order to comply with the regulatory requirements of the medical device industry it...
It helps engineers navigate the complex and evolving regulatory landscape for medical devices, including the following regulations and standards: U.S. Food and Drug Administration (FDA) Code of Federal Regulations (CFR) Title 21, Part 820. European Union (EU) Medical Device Regulation (MDR) In...
China’s NMPA has released an update of the Medical Device Standards Catalogue on January 15, 2024. It includes 1974 medical device standards.
LuminLogic is a fully configurable medical device QMS and regulatory compliance software for complete product lifecycle development.
Device recalls are costly, loss revenue can be even higher. Reduce review processes, rework, and defects early in the development process. Evolving Regulations Meet changing compliance standards while meeting critical timelines. Simplify regulatory submissions and audit preparations. Time to Market Understa...
medical device Software development services Reduce the Risk, Cost, and Time It Takes to Get Your Medical Device to Market We have the experience and infrastructure to efficiently get your medical device to market Your trusted source for medical device software from embedded to cloud ...
Besides specific cybersecurity standards, there are other supporting standards, in the domain of software development andrisk management, which cybersecurity procedural controls have to comply with. • ANSI/AAMI/IEC62304 IEC 62304 [42] is a standard formedical device softwaredevelopment, and complianc...
“We needed a SaMD partner equally versed in medical device software development and modern software engineering. Orthogonal clearly crosses that bar, and has been an invaluable asset for Boehringer Ingelheim Digital.”Janet MaldonadoHead of Engineering, Boehringer Ingelheim Digital ...
While each standard addresses specific medical device products, they collectively emphasize requirements for performance, testing, labeling, and safety measures. Here is a summary of what the newly introduced standards addresses as tailored to specific medical applications and technologies: ...