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QMENTA receives ISO 13485:2016 certification for its QMS system

By June 25, 2019 No Comments

QMENTA’s Quality Management System (QMS) is a company-wide new initiative, which has enhanced the quality of our products & services and improved our system on patient safety. We have implemented a PDCA (Plan – Do – Check – Action) cycle to improve product development procedures and to be able to analyze the system for opportunities for improvement with a risk-based approach. 

This process has been hand-in-hand with our most recent achievement on the compliance side, our ISO 13485:2016 certification, which paves the way for the company’s entrance into the clinical care market. 

QMENTA strives to offer the safest and highest quality products & services to our customers, employees and shareholders, which meet applicable regulatory, statutory, and customer requirements by following our QMS standards. 

QMENTA thus complies with quality management procedures for its strategic planning, product design, product realization, test & release, monitoring & improvement, and support processes. 

1) Strategic planning

QMENTA collects all business requirements from our customers and relevant regulations in order to determine, keep records of, and trace project objectives, scope, restrictions, milestones, resources, success measurements and more for functional requirements and software tests. 

2) Product design

We follow the Agile lifecycle model adapted to the requirements of IEC 62304 for the development of our software to offer products with superior quality and fewer risks. In addition, we conduct design reviews to evaluate the specifications, user interface or architecture in order to see if the product will achieve the business requirements and if the system is optimized and record all of our user and functional requirements.

3) Product realization 

We set up the requirements for each release, define Epics & smaller tasks accordingly to maintain a good balance between structure, flexibility, and effectiveness, and conduct an assessment for each task. 

4) Test & release 

To conduct software validation and verification, we trace the implementation process and check if the requirements are met in the final product and follow change control procedures to make sure that the software changes are implemented properly. The new version is released subsequent to the approval of the change request and the necessary tests.

5) Monitoring & improvement 

Our customers’ feedback is very important. Both their feedback and complaints are collected in our internal system to ensure that the problems are solved. We take corrective and preventive measures for the main issues pertaining to product quality. Moreover, to provide a high-quality service for our customers, we conduct regular reviews of our QMS.

6) Administration

We have documented and implemented some critical procedures to support the run of the QMS such as information security and data integrity to make sure we deliver a high-quality product to our customers.

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