Medical Device QMS Software

Quality & Document Control

Think it. Create it. Control it.

LuminLogic is a quality and regulatory management solution designed to solve real-world problems for life science and regulated companies. Enjoy unparalleled productivity, revenue growth, and business intelligence with LuminLogic Smart Enterprise Suite, Smart Solutions and Smart Teams, along with compliance controls and a robust validation package. LuminLogic Medical Device QMS Software helps you manage the process, paperwork and details for your regulated environment. LuminLogic works to:

  • Enhance collaboration of your team
  • Improve operational efficiency
  • Mitigate regulatory risks

By using LuminLogic Medical Device QMS Software, you’ll:

  • Reduce your time to market
  • Track, search, manage and access critical company information in seconds
  • Simplify work processes and information flow for individuals, teams and management
Product Features
Build and Develop a Top-Notch QMS
Robust Features Make it Possible

With LuminLogic Medical Device QMS Software there is an array of features and customizable solutions, you’ll be able to create quality and regulatory systems that meet your business’ evolving needs.

  • Reporting Capabilities

    Pull reports with just the click of a button to review issues, check progress and update executives

  • Easy-to-Read Dashboards

    Get a glimpse of your business’ most critical action items so you can proactively engage your team

  • Customizable Templates

    Create templates that meet your specific requirements to ensure processes and actions are implemented consistently

  • Set Permissions Protocols

    Make it easy for only the right people to read, write or revise items by establishing permissions down to the individual document

  • Pre-configured Controls

    Smart Teams and Smart Solutions come pre-configured with the most commonly needed folders and sub-folders for a successful QMS

  • Custom Configuration Made Easy

    Customize your solution without the need for coding experience with wizards that help you every step of the way

  • Maintain a Validated State

    Maintain your validated status with LuminLogic’s regular updates so you meet your regulatory requirements for business software

  • Support You Can Count On

    Stay on top of paperwork and cumbersome tasks with an On-Call Quality Support professional to give you a second set of hands

Customized Service Plans Include:

Training, Consulting & Implementation

to get you up and running and ensure your team works effectively in their new environment

Customer Support

to answer your questions as they relate to how LuminLogic works

Validation Options

to provide software validation strategies specific for your solution

On-Call Quality Support Team

to help prepare, review and maintain your quality documents and records, ensuring you're set up for success

Collaborative Licensing Options

to keep your sales team and vendors connected with your operation

Easy Transition from Smart Solutions to Smart Enterprise Suite

to help you grow without migration issues
Why are we the Best In offering QMS Software for Medical Devices?
  • We are Focused

    We are a focused team of experienced developers who deliver high-performance solutions. Our approach is client-focused and driven by passion and creativity. We take absolute ownership of our projects and communicate effectively with our clients. Our project management model is metric-driven and fully transparent. All our project metrics and data are available for online access.

  • Highly Skilled Developers

    Our team comprises of the most skilled QMS developers in the world. We have extensive knowledge of the tools/practices that make up great QMS software. We are pioneers in product innovation and adhere to the best industry practices in coding and security. Our developers are ready for new challenges to deliver outstanding results.

  • Our Approach

    Our approach to Quality Management Software development is unique and compelling. We analyze requirements and discuss your desired outcomes in detail before taking on a project. We are open to exploring new ideas and technology to deliver an innovative product. We build long-lasting relationships with our clients, intending to help them grow and succeed.

  • Reputation

    We have built an enviable reputation as the best QMS software firm in the last few years. Our reputation stems from our unwavering commitment to quality and customer privacy. We work closely with clients and ensure effective communication during project development. Our clients trust us for our timely delivery and contract us for long-term projects.

  • Faster Turnaround Time

    Our customer service and IT infrastructure are top-notch. We are quick to respond to on-site issues with software and adhere to SLA’s committed during launch. Our remote diagnosis service enables us to resolve a majority of issues by remotely connecting to your computers. We send out technicians the next business days to fix the unresolved problems.

  • Proven Track Record

    Our positive customer feedback and ratings are a testimonial to our unblemished track record. We have delivered time and again without compromising on quality. Our project management is result-oriented and ensures the best software development practices. We under promise and over deliver on our commitments. Our customers trust us implicitly and recommend our services.

  • Cutting Edge Technology

    Our skilled development team is cognizant of the latest software tools and technologies in the industry. We aim to build feature-packed QMS software that drives your company revenues. Our technology stack features the best coding, analytical, and testing tools. Our AI and Machine Learning expertise enable us to build robust and intelligent software.

    Are you looking for a robust Medical Device Quality Management System? Contact us now to know more.

Importance of Quality Management Software for Medical Devices
  • Extensibility 

    An inescapable requirement for a QMS software is its capability to extend itself to support growth. Its extensibility must be designed during the planning stages itself. It ensures that it can easily handle demanding volume requirements as your company grows. It must factor in employee growth along with advanced processes such as document control.

  • Adaptability 

    The ISO 13485 Quality Management System must be flexible in changing internal and market requirements. Agile-driven QMS software is ideal, as it is quicker to adapt to complex changes in your company. The software must allow easy customization and deliver robust reporting functionalities. These features make tracking your product quality easier and focused.

  • Efficiency 

    Improved efficiency is a direct result of implementing quality closed loop QMS software in your company. A QMS software continuously monitors processes, workflows, and supply chains within your ecosystem. It makes the production process efficient and reduces the cycle times for most internal functions. It evaluates and redesigns your processes for maximum efficiency.

  • Less Wastage 

    By using Quality Management Software, your production process will get benefited. It reduces the overall wastage during the entire cycle. The software identifies materials and deviations that result in wastage and eliminates them. Consequently, the cost of production reduces, while revenue increases. A QMS adheres to industry standards such as ISO to make manufacturing processes lean and efficient.

  • Reduced Problems 

    Quality Management Software forecasts possible issues and helps prevent larger problems before they occur. It strengthens and elevates your existing quality processes to modern standards. It continuously monitors your production pipeline for issues and wastage. The software learns from previous disruptions and suggests efficient processes to reduce issues. It increases your output and lowers costs.

  • Protects Reputation 

    You are always compliant when using great QMS software for manufacturing medical devices. The software encompasses industry standards and regulations to prevent compliance lapses. It inculcates strong safety and reporting culture within the organization. By adhering to these practices, your operational capability increases. It results in a positive brand reputation in the industry.

  • Fewer Risks 

    Risk management and threat mitigation are key drivers in any production ecosystem. QMS software significantly drives down problems by identifying them early. They monitor production pipelines actively and assess the risks identified. These are managed by performing analysis on factors causing them and identifying a solution. Risk management is imperative in a healthy production framework.

  • Documentation & Audit 

    A comprehensive QMS software consists of effective mechanisms for document control and audits. Version and quality control for documents, such as policies, must be part of the QMS. The Audit and inspection processes built into the software must ensure operational excellence. These features prevent compliance issues and streamline the overall production process.

  • Streamlined Activities 

    QMS software streamlines your internal processes and communication, leading to increases in productivity. A centralized system ensures clear communication and collaboration between internal teams. It makes scheduling and audit processes more structured and cohesive. It eliminates disastrous process lapses by bridging gaps in communication among teams. Several quality processes can be automated to prevent human error.

  • Automated Quality Management Workflows

    International bodies like FDA and ISO mandate automated workflows to monitor quality. It includes tracking complaints and following CAPA procedures. It drives quality within an organization and maintains operational transparency across functions. Automated workflows in a QMS reduces manpower requirements and save costs. It enhances brand value by focusing on high product quality and safety.

  • CAPA Enforced 

    Corrective Action Preventive Action (CAPA) protocols reduce or prevent quality incidents. A QMS but have CAPA principles integrated to track and resolve product issues. It must have a system to document problems and the corrective action taken to resolve them. CAPA integration reduces overall costs and improves product quality, safety, and brand reputation.

  • Compliance Built-In 

    The QMS software must be compliance-ready to meet the stringent requirements of regulatory bodies. Agencies like FDA and cGMP change guidelines often, and the software must be flexible to adapt to these changes. It must accurately guide users in performing tasks to ensure full compliance. Standard forms and procedures must be pre-built and customizable.

    Reach us to know why we are #1 in delivering Medical Device QMS Software. Call us now to learn more.

How To Find The Best QMS Software for Medical Devices?
  • Research regulatory requirements that apply to your medical device 

    Regulatory requirements vary depending on the medical device as well as the country’s regulations. Ensure that you have a strong grasp of the regulations and certifications applicable to your product. Your QMS software features and quality processes will be designed around these regulations. It ensures a culture of compliance in safety across your organization.

  • Pricing 

    Pricing is an important factor to consider before finalizing a QMS software for your medical device production. Use a checklist to determine the key purposes the QMS will serve and who will use it. It will help you decide if the QMS software needs to be feature-packed and modern or relatively inexpensive.

  • Know the software’s limitations 

    QMS software contributes to increased quality and cost savings, but it does have its shortcomings. Awareness about these will enable you to make the right choice while purchasing one. The software must be easy to implement and customize when needed. It should be user-friendly and require less maintenance and upgrades while being stable and secure.

  • Figure out the resources 

    Read reviews of the ISO 13485 Quality Management System or ask for case studies to understand its timing and resources. The software must be capable of identifying common trends in complaints and failures on the production line. It should be able to streamline quality across all the key functions while maintaining compliance. It should facilitate effective resource utilization.

  • Choose a trusted partner 

    There are a dime a dozen companies worldwide offering QMS solutions ranging from cheap to expensive. Choose to partner with a company that is reputed and trusted in the industry. They must have proven experience in implementing and supporting QMS software for small and large companies. Their policies and pricing must be transparent and flexible.

  • Expertise 

    Choose a company with extensive experience working with industries similar to yours. It will ensure that they have a firm understanding of the standard regulatory and safety procedures. Their software will be pre-built with many compliance procedures that are common to your requirements. Check their implementation history and customer feedback before finalizing your partner.

  • Integration Facilities

    The medical device manufacturing industry is ripe with innovation and advances in software. It means that the ISO 13485 Quality Management System not designed for scalability or integration will fail in the long run. Choose a product that supports seamless integration with third-party hardware and software. It should adapt quickly to integration while ensuring compliance.

    We are delivering a Medical Device Quality Management System that works to support the regulated environment your business supports. Get in touch with us to know more.

Sign Up for a Free Demo

Connect with one of our regulatory software experts to get a live demo of Methodsense’s LuminLogic in action. We’ll show you how easy it is to use, as well as how it works to support the regulated environment your business supports.

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