Charles Sternberg, Associate Editor07.27.22
Greenlight Guru, pioneer of the first MedTech Lifecycle Excellence Platform, has been certified by the International Standards Organization for both ISO 9001 - Quality Management System Requirements and ISO 27001 - Information Security Management System Requirements.
These international standards outline the requirements an organization must comply with to demonstrate its processes are sound and effective. Greenlight Guru has met these requirements and achieved certification for both their own Quality Management System and data security processes, and is able to further meet the needs of their customers.
In order to receive such certifications, an organization must go through external audits with an independent, third-party agency to verify the required processes are in place and effective for both an effective Quality Management System (QMS) and Information Security Management System (ISMS).
“These ISO certifications are a huge testament to the next step of our ongoing commitment to quality,” said Mark Alpert, director of Quality at Greenlight Guru. “This further proves to both our customers and the greater MedTech industry that we truly embody a quality culture here at Greenlight Guru and have the processes in place to monitor and ensure the effectiveness of our own operations moving forward.”
Using their own QMS software, Greenlight Guru was able to meet these process requirements and demonstrate their strategy of continuous improvement and accountability that inevitably improves the customer experience and bolsters their confidence in the organization.
“This is a major accomplishment for our team and I am elated to see their hard work recognized in these certifications,” added David DeRam, CEO of Greenlight Guru. “This is our way of assuring customers we will always be capable of delivering secure, high-quality products and services that meet industry regulations and make it easier for them to do the same.”
This announcement follows Greenlight Guru’s acquisition of Smart-Trial, the maker of the first and only Electronic Data Capture (EDC) platform designed for medical devices and diagnostics.
These international standards outline the requirements an organization must comply with to demonstrate its processes are sound and effective. Greenlight Guru has met these requirements and achieved certification for both their own Quality Management System and data security processes, and is able to further meet the needs of their customers.
In order to receive such certifications, an organization must go through external audits with an independent, third-party agency to verify the required processes are in place and effective for both an effective Quality Management System (QMS) and Information Security Management System (ISMS).
“These ISO certifications are a huge testament to the next step of our ongoing commitment to quality,” said Mark Alpert, director of Quality at Greenlight Guru. “This further proves to both our customers and the greater MedTech industry that we truly embody a quality culture here at Greenlight Guru and have the processes in place to monitor and ensure the effectiveness of our own operations moving forward.”
Using their own QMS software, Greenlight Guru was able to meet these process requirements and demonstrate their strategy of continuous improvement and accountability that inevitably improves the customer experience and bolsters their confidence in the organization.
“This is a major accomplishment for our team and I am elated to see their hard work recognized in these certifications,” added David DeRam, CEO of Greenlight Guru. “This is our way of assuring customers we will always be capable of delivering secure, high-quality products and services that meet industry regulations and make it easier for them to do the same.”
This announcement follows Greenlight Guru’s acquisition of Smart-Trial, the maker of the first and only Electronic Data Capture (EDC) platform designed for medical devices and diagnostics.
