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Quality

Modulim is committed to meeting regulatory and customer requirements, enhancing customer satisfaction through continual improvement of our products and services, and maintaining the effectiveness of our quality management system.

ISO certification

In early 2018, we were awarded the International Organization for Standardization (ISO) 13485:2016 certification for our medical device Quality Management System.

Outsourced processes are controlled and monitored closely by Modulim’s Quality Assurance team. All quality metrics are mandated and actively managed by senior management.

Product vulnerability disclosure reporting

 

With the rapid evolution and digitization of healthcare technology, cybersecurity has become an integral part of our focus on safety.

 

We recognize the valuable efforts that cybersecurity researchers have played in highlighting vulnerabilities and concerns. To effectively partner with the security experts and better leverage their findings, we have joined other members of MedISAO (an Information Sharing and Analysis Organization for the Medical Device Community) in a Coordinated Vulnerability Disclosure Process designed to promote collaboration and external party reporting of medical device vulnerabilities.

 

Please note, this process is NOT intended for technical support information on our products or for reporting Adverse Events or Product Quality Complaints. If you need to report one of these, please contact Customer Service at (949)-825-5080.

 

Download our complete Product Vulnerability process here.