StartUs Insights Recognizes Qualityze Inspection Management Solution Among Top 5 Inspection Solutions for Process Industries

StartUs Insights recognized Qualityze Inspection Management Solution as the best tool to standardize, streamline, and automate the production operations to eliminate product quality and supplier risks in the initial stages. It is our commitment to quality and excellence that drives us to deliver more competent and innovative solutions. As a result, we enable organizations to […]

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 Software 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 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

How Does Qualityze Works for Medical Devices Industry?

Qualityze is a fully configurable Quality Management Solution for the Medical Device 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:

EQMS software for Medical Devices Industry

How Does Qualityze Works for Medical Devices Industry?

Qualityze is a fully configurable QMS Software for the medical device 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:

Nonconformance management software for medical device industryNonconformance Management

Having Qualityze Nonconformance Management Software for medical device companies is a perfect solution to identify and document the nonconformances in a well-organized and structured manner. Since it’s still a challenge for the organizations dealing in medical devices and drugs industry, our solution is equipped with all the features that you may need for quick documentation as well as the search of a non-conformance record. Qualityze enables you to do a detailed evaluation of product quality while complying up with the regulatory standards and company standards for tracing every single nonconformance. This cloud-based solution also helps you to specify the desired action plan for a nonconformance based on its risk severity issue to classify the ones to be processed under CAPA.

CAPA management software for medical device industryCAPA Management

Qualityze CAPA Management Software for medical devices comes with configurable workflows so that you can implement the best root cause investigation tools to identify the actual cause of the problems already occurred. You can also identify the potential causes that can result in quality issues to make a proactive approach with our advanced CAPA management software. The user-friendly interface of the software eases managing the entire CAPA cycle for you from root cause identification to implement action plans and check their effectiveness. Moreover, ours is an integration-enabled solution for improved decision making.

Document management software for medical device industryDocument Management

Medical device industry, unlike any other industry, has much more complex documentation to handle including design instructions, SOPs, specifications, manuals, and much more to ensure all the regulatory guidelines are followed. Qualityze document management solution for medical devices is designed to help you with the creation, categorization, review, version control, approvals, release, safety, collaboration, and many more document control and management functions for such complex documents. Ours is an intuitive ISO 13485 QMS software to help manage all the critical documents in a centralized repository without extensive technical training.

Change management software for medical device industryChange Management

With Qualityze Change management software for medical devices, your organization will have a smoother transition through the changes implemented due to ever-growing customer requirements and ever-changing regulatory standards. Our solution helps you to keep your workforce informed about new changes so that they can implement best practices for introducing change without facing any resistance. Our solution can help you with every aspect of change management from initiation, verification and validation, review, approval, execution, till final closure. Moreover, you can integrate this with other quality systems for the finest flow of changes.

Audit management software for medical device industryAudit Management

Keeping medical devices companies compliant with the complicated regulatory standards becomes easy with Qualityze Medical Devices Audit Management System. It is a cloud-driven solution that offers unmatched flexibility and scalability for different types of audits including internal, external, operational, suppliers, IT, and quality audits. The main objective is to ensure quality processes, products, and services. It’s quite efficient to help you manage the end-to-end audit lifecycle – planning and scheduling audits, defining the regulatory standards to prepare checklists, conducting and analyzing audits, tracking and analyzing the final audit results.

Training management software for medical device industryTraining Management

Keeping organizational productivity and efficiency to the maximum is only possible when the employees are competent and trained enough to perform the designated responsibilities. Considering the criticality involved in medical devices, Qualityze Training Management Software is designed to implement effective training sessions for your workforce. From creating course and employee profile till course completion and certification, you can track the complete progress of your employees. Serving training needs for your employees will keep them motivated and engaged in business goals achievement.

Supplier Quality management software for medical device industrySupplier Quality Management

Built on cloud platform i.e., Qualityze supplier quality management software is the best solution to manage all your supplier related tasks from creating supplier records to monitor their performance on a regular basis. The ease, convenience, and accuracy that Qualityze offers are incomparable. Most importantly, our supplier quality management software complies with different internal and external regulatory standards in order to ensure quality supply chain processes. Moreover, you can leverage a centralized platform to improve collaboration and communication with all your suppliers.

Complaints management software for medical device industryComplaints Management

Transforming customer complaints into improvement opportunities is a need for every industry especially the medical device industry. Qualityze Complaint Management System helps you do exactly what you need to maintain a healthy relationship with your loyal customers. It allows you to track and manage every customer complaint/feedback in a systematic order so that you can deal with them effectively and limit their recurrence especially the issues that qualify for CAPA investigation. It is the most effective system to manage entire complaint lifecycle including documentation, initiation, investigation, reporting, and closure.

Calibration management software for medical device industryCalibration Management

Health and safety of patients are the top priorities for medical device manufacturers. The equipment used in production should be accurate and precise. It requires them to manage calibration programs regularly. And, Qualityze Calibration Management Solution is the most reliable tool to schedule, manage, and track the equipment calibrations. It also helps medical device companies to stay compliant with ISO 13485 and 21 CFR parts 11 and 820. Our solution help ensures that calibration programs are executed regularly as scheduled by sending alerts to the involved parties. If you want to minimize the measurement uncertainties, get Qualityze to manage equipment calibrations.

Maintenance management software for medical device industryMaintenance Management

Managing medical devices has recently gone to the next level of complexity because of the equipment sophistication and specialization. There is a need for regular maintenance and repair activities to achieve safety, compliance, accuracy, and reliability. Qualityze Maintenance Management Solution helps you address all the maintenance needs of medical devices at the right time to avoid any catastrophic events. Our solution also helps to store the historical data and perform maintenance audits of all the medical equipment used at regular intervals. It improves overall efficiency and decreases costs significantly.

Inspection Management Software for Medical Device IndustryInspection Management

Inspecting medical devices for safety and performance has become even more critical, with regulatory requirements getting stringent. Qualityze Inspection Management enables streamlining all your inspection-related activities to ensure the safety, quality, and reliability of medical devices to supply the best care. It is a cloud-based, fully configurable solution to simplify medical device inspections and to meet compliance. It keeps an audit trail for all the inspection activities to leverage increased traceability and improved decision-making. It comes with excellent built-in capabilities like E-signature, Email Approval, Dashboards, and many more. With Qualityze Inspection Management, you can experience the simplified way of managing inspections and compliance.

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

Still Thinking?

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.

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