(Greenlight Guru: Indianapolis) -- Greenlight Guru, creator of the only quality management software designed specifically for the medical device industry, announces new software platform updates to align with the recently updated ISO 14971:2019 standard, as well as further enhancements to the change management capabilities that debuted in December 2019.

ISO 14971 is the predominant standard for risk management in the medical device industry, of which compliance is required in the United States, Canada, and the European Union. 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.

“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,” says Jon Speer, founder and vice president of QA/RA at Greenlight Guru. “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.”

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