Quality Management System for Medical Devices
For the medical devices industry wherein quality and highly regulated environment are a must, you cannot rely on the traditional quality management systems. Since most of those QMS is merely a combination of some general-purpose tools and paper-based processes, bonded together by a group of people more like a loosely held system. The lack of accountability and traceability are the key factors that make such medical device QMS ineffective. Hence, there is a need for powerful QMS for medical devices industry that can manage all the quality processes within a closed-loop system.
Qualityze, the next generation quality management software for medical device industry is built on the Salesforce.com platform. A cutting-edge enterprise cloud platform with flexibility, ease of use, risk mitigation and compliance enabled. The QMS for medical devices companies provides you with a closed loop EQMS system that enables you to be compliant with internal and external regulations. Qualityze enables you to comply with ISO 13485 standards US FDA (21 CFR part 11, 21 CFR part 820), Therapeutic Goods Administration (TGA), and Pharmaceuticals and Medical Devices Agency (PMDA).
The Qualityze EQMS software for medical devices is a closed-loop quality system which includes Document Management, Change Management, Nonconformance Management, CAPA Management, Audit Management, Training Management, Complaints Management, Supplier Quality Management, Calibration Management, Maintenance Management, Inspection Management with exciting features like Audit Trail, Electronic Signature, Validations, Dashboards, Reports, and Analytics.
Advantages of a Quality Management Software for Medical Devices Companies
The precision of design and manufacturing is a must in the medical devices industry as they can be of huge impact on lives for the good or worse. Quality standards are critical to reaching high levels of product reliability in production.
You must adhere to ISO 13485 in order to meet all the quality management system standards for medical devices. Here’s an overview of all the benefits that you can leverage with the integration of an end-to-end quality management software for medical devices:
- Effective and Faster Cycles of Execution
- Increased Customer Satisfaction
- Elevated Market Value
- Reduced Amount of Waste
- Streamlined Process Improvements
- Improved Supplier Relationships
Effective and Faster Cycles of Execution
One of the most important benefits of integrating a closed-loop quality management system for medical devices is faster cycle times for both the supply chain operations and production. The reason for faster cycles is that the processes, products, and systems are continuously reviewed and redesigned for maintaining a culture of continuous improvement for quality management. You will witness faster cycle times and improved service in every business process from administration to accounting, quality check to quality control, and purchase.
Reduced Amount of Waste
When your organization conforms with the ISO standards and other industry-specific regulatory requirements, there will be lesser waste during the production process. The deployment of an effective quality management solution helps medical device companies to identify and remove the excess materials, overproduction issues, waiting, deviations, and scrap. In addition to this benefit of QMS, you will also experience fewer internal failures issues with machinery and lesser customer complaints. As a result, you will have lower costs of production and higher profits. A significant decrease in labor hours will allow relocating your resources to other activities, increasing cost-savings.
Increased Customer Satisfaction
Medical Device Quality management systems help you to cut the costs of non-conforming products while adding to customer satisfaction. This is applicable for the suppliers as well who deliver quality raw materials and required components for the products that can improve customer experiences. It is the fact that medical devices have a huge impact on people’s lives and even a minor error is of zero tolerance. For example, if you will have all the processes controlled, you will have lower chances or no chances of variations in the machining process. This will allow you to create a product that matches the design thresholds. It will contribute to the quality of life for customers as the precisely manufactured medical devices can easily withstand environmental strains and will serve their intended purpose.
Streamlined Process Improvements
In an industry like medical devices, the quality management system can be of great help in streamlining the organization’s internal communication by creating a centralized system to manage all the quality processes. You will experience a lot of improvements in other processes like scheduling a review, audits, follow-up, corrective action, etc. due to automation. There will be a reduced number of loopholes, unlike traditional systems that have higher chances of miscommunication, or delayed information. The next generation medical device quality management software is capable enough to streamline quality processes while filling the communication gaps effectively and efficiently.
Elevated Market Value
The medical device companies that meet ISO requirements can market their products and services in a better way. Their ISO certification reflects that they have attained the standard of excellence, which enables them to have a competitive advantage in the marketplace. The market value and enhanced efficiency that comes with ISO:13485 itself justify their standardization. What else? when you have the best quality medical devices, operations profitability, and high morale employees to reach a higher level of excellence, which will drive improved business outcomes.
Improved Supplier Relationships
You can also set the supplier quality standards high while managing them through advanced quality management systems. Most of the medical devices’ companies don’t realize the significance of maintaining supplier quality even today that makes them lag in the race of excellence and product quality that drives customer satisfaction. They need to have an efficient and effective quality management software to monitor the supplier performance, ensuring that their process and product quality adheres to compliances.
How Does Qualityze Works for Medical Devices Industry?
Qualityze is a fully configurable Quality Management Solution for Medical Devices Industry that helps to standardize the processes and workflows to meet the quality specification highlighted by the regulatory compliances, ensuring customer satisfaction. With 11 different modules, Qualityze is an EQMS suite that deals with complex medical devices quality instructions in a simplified manner. Let’s have a look at how each module functions for the medical device industry:
Why Choose Qualityze Enterprise Quality Management Solution for Medical Devices industry?
Choosing Qualityze Enterprise Quality Management Solution will be a beneficial decision for the Medical Devices industry because it has
Qualityze EQMS has a lot of value to offer to any organization with its customizable cloud-based software for Nonconformance Management, CAPA Management, Document Management, Change Management, Training Management, Audit Management, Supplier Quality Management, Complaints Management, Calibration Management, Maintenance Management and Inspection Management.