Quality Management System for Medical Devices

Qualityze Inc attends ISO 9001 and Audits World Conference, gains valuable insights on quality management and auditing!

Tampa, FL USA, 23rd March 2023: Qualityze is pleased to announce our recent participation in the ISO 9001 and Audits World Conference. The event took place on March 13-14, 2023 and brought together professionals around the globe to discuss quality management and auditing. The ISO 9001 and Audits World Conference is a premier event in […]

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 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, EBR Management, Audit Management, Training Management, Complaints Management, Supplier Quality Management, Calibration Management, Incident Management, Field Safety Action Management, Permit Management, Material Compliance Management, Forms 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 Devices Quality management system 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 QMS 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 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 16 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 16 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. Salesforce.com, 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.

Permit Management Software for Medical Devices IndustryPermit Management

There is a formal registration process for medical device facilities to follow in nearly every region worldwide, which varies slightly between them. The registration of your device is not only required during the initial registration but may need to be renewed every year. In addition, before manufacturers apply for a Medical Device License, they need to be certified using the Medical Device Single Audit Program (MDSAP). In the same way that the FDA collects licensing fees from U.S. medical device manufacturers, distributors, and importers, Health Canada does so. It can be difficult to manually manage several aspects of medical device registration and licensing. Qualityze Permit Management can make it easy and efficient for you.

Material Compliance Management Software for Medical device IndustryMaterial Compliance Management

Medical device companies must align their processes with best practices to stay compliant and deliver safer products. As a result, they need a robust solution like Qualityze Material Compliance Management to integrate their quality and compliance initiatives. The solution makes regulatory compliance a strategic initiative for medical device companies. It can be easily integrated into existing supply chains design and manufacturing systems, supporting efficient data collection, reporting, and traceability. The exceptional capabilities and features ensure that the reporting declarations associated with the components used in medical device production are filled, managed, controlled, tracked, and distributed in a high-quality environment. In addition, it enables medical devices to demonstrate compliance with applicable regulatory standards such as EU Medical device materials restrictions, FDA Latex, and much more.

Forms Management Software for Medical device IndustryForms Management

Medical technology is heavily reliant on data. There is no doubt that customers’ data is the most valuable resource for medical device manufacturers to extract granular insight into their needs and behaviors. Moreover, it can spark innovation and boost competitiveness by taking full advantage of such data requires a well-designed master data management strategy. These manufacturers can only comply with customer specifications and regulatory oversight by successfully collecting, recording, reporting, and analyzing manufacturing and product performance data to obtain mission-critical certifications, like FDA or EMA certificates. That’s where Qualityze Forms Management plays a critical role. It helps collect, share, and analyze forms data to predict failures and possible success paths. It enables your teams to quickly configure the forms for different business and compliance requirements. You can also digitally validate the form inputs to ensure data quality.

Field safety Management Software for Medical device IndustryField Safety Action Management

Medical device manufacturers must document the corrective measures they take when a suspected or confirmed nonconformity arises and the risk assessment that results from those measures. In addition, the manufacturer must ensure that all corrective or preventive actions are evaluated within a specific timeframe to demonstrate (and document) that the measures taken were indeed effective. Finally, manufacturers should also ensure appropriate communication with the relevant economic operators and competent national authorities (NCAs) within the EU member states. You can streamline all these post-market surveillance activities with excellence using Qualityze Field Safety Action Management Solution. It enables enterprises to manage end-to-end product safety to keep customers safe. In addition, the software simplifies recall management and regulatory reporting, ensuring that you remain compliant.

Incident Management Software for Medical device IndustryIncident Management

In accordance with the Medical Devices Directive 93/42/EEC, manufacturers must notify the CA of the state where incidents occur. Incidents could include device malfunction, the technical or medical reason that hindered the performance of medical devices, and other reasons that can further lead to an incident if not controlled timely. The regulatory standards require manufacturers to comply with the Post-Market surveillance aspects, including integrating incident reporting into the quality system and reporting within minimal time. Unfortunately, the outdated technology systems may not pace up with such comprehensive requirements. It would be best to upgrade to a next-generation Inspection Management Software like Qualityze. It helps streamline the end-to-end incident workflows, including the documentation, so you always remain compliant. With the configurable workflows and intuitive interface, you can design the processes in the desired order without extensive training. Most importantly, your incident records will be securely stored in a centralized system.

EBR Management Software for Medical device IndustryEBR Management

Every batch record in the medical device industry is crucial since it contains information about equipment, materials, employees, data, labels, events, supplies, laboratory information management systems, process control systems, and enterprise resource planning systems. Thus, each Batch Record will contain test results for both the in-process and release phases. By providing this information, you can assure governmental agencies and internal stakeholders that your products meet industry standards. However, managing batch records using a paper-based system will be inefficient. Qualityze Electronic Batch Record Management makes it simpler and more efficient for you. It comes with pre-defined templates that relieve you from additional administrative tasks to creating batch production records and maintaining consistency. In addition, the digital signature validation at every step helps you demonstrate best practices and meet compliance with FDA Part 11. Check out other in-built capabilities in real-time by requesting a free demo. 

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, Permit Management, Material Compliance Management, Forms Management, Complaints Management, Incident Management, Field Safety Action Management, EBR Management, Calibration Management, Maintenance Management and Inspection Management.

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