How Greenlight Guru are ensuring compliance with ISO 14971:2019
Greenlight Guru, a Medical Device Quality Management System (MDQMS), has enforced new software platform updates to ensure the company is complying with the recently updated International Organisation for Standardization (ISO) 14971:2019 standard.
The organisation are also implementing further enhancements to the change management capabilities they debuted in December 2019.
ISO 14971 is the main standard for risk management in the medical device industry. The legislation which came into effect in December 2019 is the latest update to the application of risk management for medical devices. The purpose of this standard is to better define key terminology, residual risk identification, and personnel competence. This level of compliance is required in the United States, Canada, and the European Union.
“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, 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.”
The updates to the Greenlight Guru platform will reflect changes to align with ISO 14971:2019, as well as several productivity enhancements. These updates include:
- The debut of group management, which gives companies the flexibility to create and manage different groups of employees based on how their teams or organisation are uniquely structured.
- Enhanced change management capabilities intended to assure medical device companies are systematically assessing the impact of changes through built-in change evaluation functionality.