REGULATIONS

Meet FDA and EU Requirements

Satisfy Quality & Regulatory Requirements

Notifying bodies in the US and EU strive to ensure that medical devices are safe for patients and operators. Determining this safety is often rigorous, time consuming and document heavy. LuminLogic’s combination of Medical Device Project Management Software and consulting services pair to position your life science product and business operations for commercial success.

Below are just a few of the regulations LuminLogic can help you with:

FDA 21 CFR Part 11 & Annex 11

Confidently manage your quality, manufacturing, business processes

FDA 21 CFR Part 820

Create a Quality System that demonstrates the safety and effectiveness of your device

IEC 60601-1 3rd Edition A1

Achieve easier compliance, faster validation, and better process management

IEC 62304

Keep your Software Development Life Cycle activities organized and readily available
FDA 21 CFR Part 11 & Annex 11
FDA 21 CFR Part 820
IEC 60601-1 3rd Edition A1
IEC 62304

FDA 21 CFR Part 11 & EU Annex 11 Compliance

Why implement a 21 CFR Part 11 and Annex 11 Compliant Software Solution?

The FDA requires life science companies to implement controls on the systems used to manage electronic records that are required by predicate rules or submitted to the FDA. Likewise, the European Medicine Agency (EMEA) requires similar controls for Annex 11 of the Medical Device Directive.

At its core, LuminLogic is designed to be 21 CFR Part 11 and Annex 11 compliant. Not just so we are meeting regulations, but to help life science organizations effectively realize their informational values around data integrity, authenticity, nonrepudiation and security. These values are important to your Intellectual Property and confidential information, as well as your regulatory documents.

FDA 21 CFR Part 11 & EU Annex 11 Compliance Solutions

Our combined solution of LuminLogic’s software and our regulatory experts allow you to confidently manage your quality, manufacturing, business processes and much more, with document control, record retention and audit trails.

LuminLogic supports 21 CFR Part 11 & Annex 11 compliance by:

  • Pre-validating the solution
  • Maintaining electronic records and their copies in auditable condition
  • Delivering audit reports designed for the auditor
  • Providing controls over content and its management
  • Limiting access to authorized individuals, while accelerating collaboration

Your LuminLogic solution delivers easier compliance, more efficient validation and improved process management.

Why wait any longer? Contact us today to get started with your 21 CFR Part 11 medical device project management software solution.

FDA 21 CFR Part 820 Compliance

Meet FDA QSR Requirements for Medical Device Manufacturers

Medical device manufacturers must establish quality systems and design controls to ensure that their products meet applicable requirements and do not pose unacceptable risk to the consumer or public. FDA 21 CFR Part 820 is the Quality System Regulation that outlines current Good Manufacturing Practice (cGMP) requirements. Without a compliant Quality System, your device cannot be made available for commercial use.

FDA 21 CFR Part 820 Compliance Solutions

LuminLogic was developed to provide the infrastructure necessary for 21 CFR Part 820 requirements. This includes controls and collaborative capabilities for device:

  • Design
  • Manufacture
  • Packaging
  • Labeling
  • Storage
  • Installation
  • Servicing
  • Technical files

With LuminLogic’s medical device project management software solution and support from our regulatory experts (at MethodSense), you can create a Quality System that demonstrates how you have built safety and effectiveness into your device.

Be prepared for your next FDA inspection – contact us today.

IEC 60601-1 3rd Edition A1 Compliance

Provide structure to your medical device risk management program

For those who design or manufacture electromedical equipment, IEC 60601-1 3rd Edition A1 is one of the most important safety and performance standards to meet. The standard addresses critical safety issues, including the risk of electrical shock, fire hazards and mechanical hazards, such as entrapment risks. Devices that must meet current IEC 60601-1 requirements include those which:

  • Diagnose, treat, or monitor the patient under medical supervision
  • Make physical or electrical contact with the patient
  • Transfer energy to or from the patient; and/or
  • Detect such energy transfer to or from the patient
IEC 60601-1 Management Solutions

Meeting the requirements of 60601-1 3rd Edition documentation requirements can be extensive. LuminLogic’s solutions and MethodSense’s regulatory expertise provide structure to your product documentation for easier compliance, faster validation, and better process management – so you can meet your commercialization goals sooner.

LuminLogic helps you meet IEC 60601-1 3rd Edition A1requirements by:

  • Easy, yet controlled, access to your most current relevant risk management and other GMP procedures
  • Organizing IEC 60601-1 and other relevant tables
  • A secure collaborative environment between quality, regulatory and engineering personnel with the appropriate document management and version controls to enable a smooth work process
  • A portal with role-based security to exchange content efficiently and conveniently with your Notified Body

Contact us today to ensure your device gets to market quickly and without unnecessary delay!

IEC 62304 Compliance

Meet the software development lifecycle requirements of IEC 62304

If your medical device has software that regulates its functionality in a way that contributes to Basic Safety or Essential Performance, then you will need to comply with IEC 62304. The standard requires all aspects of the software development life cycle (SDLC) to be appropriately managed to ensure patient safety, including:

  • Development and code reviews
  • Risk management
  • Configuration management
  • Incident and bug resolution
  • Validation
  • Maintenance
IEC 62304 Management Solutions

All these SDLC activities generate a great deal of documentation that can be difficult to keep organized and readily available when they are needed. LuminLogic’s solutions, combined with the regulatory expertise of our consultants, allow you to implement your IEC 62304 SDLC management documentation for easier compliance, faster validation, and better process management – so you can meet your commercialization goals sooner.

LuminLogic helps you meet IEC 62304 requirements by:

  • Easy yet controlled access to your most current relevant SDLC and other GMP procedures
  • Incident and bug management that is traceable to your validation package
  • Organizing IEC 62304 and other relevant tables
  • A secure collaborative environment between quality, regulatory and software development personnel with the appropriate document management and version controls to enable a smooth work process
  • A portal with role-based security to exchange content efficiently and conveniently with your Notified Body

Contact us today to ensure your device gets to market quickly and without unnecessary delay!

Be Competitive: Meet IEC 62304 Regulatory Requirements

Learn how LuminLogic can help you fulfill your Software Development Lifecycle requirements!
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LUMIN LOGIC
Why Are We the Best in Offering Project Management Software for Medical Devices?
  • Vast Knowledge & Experience 

    Our team is renowned for its prowess in developing world-class project management software. We have years of experience in building software solutions that drive successful projects. Our knowledge of software design and development is extensive and spans the latest technology. Our designers and developers come with impeccable qualifications and certifications in the world.

  • Transparency 

    We believe in a culture of transparency and honesty. We discuss every aspect of the project without reservations. We are transparent about our timelines and pricing. We work closely with our clients and provide regular status updates about the development. There are no hidden charges with us, and we never charge you for unnecessary features.

  • Brilliant Team 

    Our winning team has won multiple accolades from customers and industry leaders over the years. We have the most skilled and innovative group of designers, developers, and project managers. We love challenges and drive the spirit of collaboration within us. Our enthusiasm and talent help us build the best project management software for your business.

  • Client Retention Percentage 

    We are proud of the large volume of clients who retain our services year upon year. Our clients place immense trust in us for timely delivery and exceptional customer service. We provide seamless remote and on-site assistance to support our project management software. Our customer retention percentage is higher than 90% and continues to grow.

    LuminLogic is providing Healthcare Project Management Software in NC. Get in touch with us to know more about our compliant SaaS solution.

Eight Tips to Choose the Best Project Management Software For Medical
  • Should Know the Basics of SaaS  

    Investing in software as a service (SaaS) solutions may be cheaper with fewer overheads, but it comes with its shortcomings. Most often, companies who offer subscription change features and the user interface. It leads to confusion and disruption among your teams. Go ahead with a SaaS solution only when you have control over the interface.

  • Plan for regular maintenance 

    Effective project management software needs periodic maintenance and upgrades for the best performance. The technology and security landscape changes constantly, and it’s important to keep track of it. It prevents security vulnerabilities and ensures that your project management software remains relevant. Preventive maintenance will help you eliminate bugs and ensure peak performance always.

  • Comprehensive Collaboration 

    Seamless collaboration among project teams across functions is essential in an organization. Project management software must empower teams to work together with a high degree of efficiency. It must allow teams to share information and track projects on-site or remotely. Collaboration features in project management software increase overall productivity and transparency.

  • Safety 

    Security is a key requirement in project management software. Safeguarding internal, as well as any confidential customer data, is crucial. The project management software must adhere to the best security practices in the industry. It includes file encryption, access control, and secure storage. Never compromise on security when purchasing a project management software.

  • Reporting Solutions 

    Analytics and accurate reporting of metrics drive quality and performance in a company. A project management software for manufacturing medical devices must come with analytical tools. It helps you generate real-time reports during any stage of the manufacturing pipelines. Access to this data can help you make impactful decisions that save costs and improve quality.

  • Cost 

    Always consider your budget and what features of a project management software you are willing to invest in. Not all features would be applicable for your manufacturing or project operations. This analysis will help you determine the price of the software. Consider the periodic maintenance and upgrade costs, which are essential for any software.

  • Swift Integration 

    A desired feature in any project management software is the ease with which integrations can be performed. The software should allow seamless and swift integration with third-party software, plugins, or modules. It should support communication between various platforms like cloud or mobile. The capability to integrate other tools quickly enhances productivity and collaboration.

  • Task Administration 

    Managing key project-related tasks is an essential feature in any project management software. The software must have an intuitive and effective workflow to create and assign tasks to users. It should allow key stakeholders to view a task status at any stage and make necessary changes. Effective task management is the key to success.

    If you are looking for the best Medical Device Project Management Software, get in touch with us now!

Benefits of Project Management Software for Medical Devices
  • Improved Scheduling

    Project Management Software gives you superior control over scheduling activities. Using Gantt charts and other project tracking widgets present a clear picture of the project at any time. The software enables project administrators to add and remove people from a project. It also allows them to track activities and restrict access to non-authorized persons.

  • Good Communication with Customers 

    Improved and effective communication with clients is a benefit of Project management software. Your clients can access major project-related dashboards anytime from a standard web browser. All they need are logon credentials. They are updated in real-time about project progress and any challenges. It makes communication with clients timely and efficient resulting in improved performance.

  • Resource Allocation 

    It is imperative to manage your project resources efficiently without overburdening team members. A project manager needs a clear picture of the team’s schedules and assigned tasks during the project life cycle. Project management software eases this tricky task by displaying key data in an easy to read format.

  • Increased Customer Satisfaction 

    It is no secret that your clients are thrilled and respect you when quality work is delivered on time. Collaboration and quality control tasks performed by a project management software helps with it. Diligent planning and tracking projects with the software save time and cost. Enhanced customer satisfaction improves your company’s reputation in the industry.

  • Delegate Tasks Easily 

    A medical device manufacturing project contains multiple different pieces that work together. Efficient synchronization between teams leads to a quality product and saves costs. Project management software simplifies task delegation and tracking. The accountable people assigned to the tasks are notified and can share updates on the task progress. The process is transparent to stakeholders.

  • Improved Productivity 

    The biggest benefit of implementing a project management software is the rise in productivity. Project teams are better coordinated and know their respective roles. It’s easy to delegate and track tasks using dashboards and detailed analytics. Teams save a lot of time in communication. All these benefits lead to a lean but productive company.

  • Better Collaboration 

    Project management software fosters strong collaboration within diverse functions within a company. It saves time from physically meeting different stakeholders to discuss project updates. Teams can view the roadblocks and upcoming project deliverables at any time for the whole project. It helps in identifying process gaps and bridging them to ensure timely project delivery.

  • Document Sharing and Access 

    A handy feature of Project management software is the ease with which documents can be shared among teams. You can store Documents on a central and secure repository—the project administrators control which users have access to a specific document based on their project roles. Audit trails enable administrators to track any file uploads and downloads.

    Get in touch with us to know more about our compliant med device management suite. It is the best Project Management Software for Medical Devices.

Four Medical Device Project Management Tips
  • Know your project in and out 

    Project management software won’t help much if you don’t your project extensively. You must be clear about the outcomes you expect and the project timelines. Have a clear budget and an idea about the key teams you will need to bring together. Maintain a checklist to ensure all deliverables are tracked.

  • Determine the risks 

    Identify early in the planning stage the possible roadblocks you may encounter. It helps in engineering the project management software to mitigate any risks. Identify the factors that may hinder the development of world-class medical devices. Work with other functions and external vendors to efficiently eliminate risks. Be prepared with alternative solutions during a crisis.

  • Communicate Often 

    Any gaps in communication between core teams in a production pipeline lead to delays and diminished quality. Project management software helps in establishing streamlined communication. Ensure that your clients can view project status reports easily and can provide inputs immediately. Key functions in the company must have visibility of the tasks being performed by others.

  • Conduct a review after project completion 

    There are plenty of things are project team can learn by introspecting on a project after completion. A project retrospective helps identify things that went well and those that caused roadblocks. This learning can be used in future projects to increase productivity and make the teams efficient. Ensure that you document all learning for reference.

    Are you looking for a Project Management Software for Medical Devices? We’re Here to Help. Contact us now!

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