Greenlight Guru today announced new software platform updates to align with the recently updated ISO14971:2019 standard, as well as further enhancements to the change-management capabilities the company debuted in December 2019.
ISO 14971 is the predominant standard for risk management in the medtech industry. Put into effect in December 2019, ISO 14971:2019 is the latest update to the application of risk management for medical devices. It serves to define better key terminology, residual risk identification, and personnel competence, according to the Indianapolis-based company.
“This iteration of the ISO 14971 standard is the first update in nearly 13 years, and offers much-needed clarifications to reflect current best practices,” said Jon Speer, VP of quality assurance and regulatory affairs at Greenlight Guru, in a news release. “The update to our platform not only conforms to the new standard but represents our continued dedication to being the best quality management system for medical device companies.”
Updates to the Greenlight Guru platform reflect changes to align with ISO 14971:2019 as well as several productivity enhancements, including enhanced change-management capabilities intended to assure medtech companies are systematically assessing the impact of changes through built-in change evaluation functionality. The update also introduces group management, which gives companies the flexibility to create and manage different groups of employees based on how their teams or organization are structured.