Greenlight Guru, a medical device quality management system (MDQMS), has announced new software platform updates in order to align with the recently updated International Organization for Standardization (ISO) 14971:2019 standard, as well as further enhancements to the Change Management capabilities they 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 VP 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.”
Greenlight Guru’s timely platform update to help medical device companies comply with these changing regulatory standards is proof that they eliminate the burden of allocating internal resources to update the design and quality processes for customers, allowing them to stay current with evolving industry regulations and compliance requirements.
Updates to the Greenlight Guru platform reflects changes to align with ISO 14971:2019, as well as several productivity enhancements, including:
- Enhanced Change Management capabilities intended to assure medical device companies are systematically assessing the impact of changes through built-in change evaluation functionality
- The debut of Group Management, which gives companies the flexibility to create & manage different Groups of employees based on how their teams or organization are uniquely structured