SERVICES

Quality and Regulatory Consulting

Services

If you’ve come here looking for help, you’re in the right place. Do you need quality, regulatory product specific expertise? LumingLogic provides the following services:

Quality and Regulatory Consulting

  • MethodSense, the parent company to LuminLogic, is a best in class life science consulting firm. Their expertise, repeat success stories and first-hand knowledge and passion help you get going fast, and keep you going strong! From 510(k) submissions to Product and Software Development Lifecycle Management to Quality System Management, our life science and FDA Quality ,Regulatory and Engineering Consultants have the experience to help you bring your product to market without unnecessary delay. Contact us today to learn how we can help you!

LuminLogic Support

LuminLogic provides customer support services, fast product implementation and deployment and validation efficiency. To get in touch with one of our product experts, simply reach out to us by phone or email. We’re ready to help.

SERVICES
Consulting
Our Expertise, Your Business, Proven Results

When you implement LuminLogic to address medical device compliance, quality management, product development and corporate governance needs, you benefit from the additional support of our professional Regulatory, Quality and Engineering consultants ready to answer your questions.

MethodSense, the parent company to LuminLogic, is a life science consulting firm with expertise and first-hand knowledge and passion help you get going fast, and keep you going strong!

Consulting for global compliance needs includes:

SERVICES
On-Call Quality Support
Maintain Compliance With Quality Support
Quality Support When You Need It

On-Call Quality Support is a unique pairing of our software – with all its controls – and our expertise as quality and regulatory consultants. For a proven way to reduce risk and costs, get fast results and get the most from LuminLogic, trust our team to guide you.

We know firsthand that the most difficult aspect of compliance is maintaining it. Every year. Every month. Every week, there are actions that must be taken to demonstrate you’re in compliance with your ISO 13485 Quality Management System. When you’re not compliant, or can’t demonstrate that you’re in compliance, you could face lost opportunities and costly setbacks.

Without On-Call Quality Support, you’ll be asking questions like:

  • What if our company is audited tomorrow?
  • What if a potential partner can’t see how we’re managing our business?
  • What might noncompliance cost us?

With LuminLogic as your solution, you benefit from the additional support of an On-Call Quality team to prepare, review and maintain your documents and records, ensuring you’re set up for success. When you have more in depth needs, we’ll put you in touch with regulatory and quality assurance consultants from MethodSense, giving you the complete resources you need for operational success!

Minimize Risk: Get On-Call Quality Support to Maintain Compliance

Demonstrate that you're in compliance by fulfilling what you said you would do in your Quality System!
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Quality Support

When You Need It

    SERVICES
    Training
    Training to Maximize Success

    Trained employees mean higher user adoption rates. Help your employees be more productive by giving them the training they need to be successful. LuminLogic’s training programs empower your employees to effectively support your organization by:

    • Reducing the risk of non-compliance
    • Reducing the cost of quality and safety
    • Protecting your most valuable asset: Intellectual Property

    Our customized training sessions are designed specifically for your solution and offer:

    • A functional overview of the software
    • Instruction directly related to your regulatory and operational needs
    • Detailed practice of the your set up and processes
    • Custom training programs for specific learning requirements

    Train users at LuminLogic’s facility or in instructor-led virtual classes. We’ll even come to you to train your entire team!

    SERVICES
    Validation

    LuminLogic recognizes that the Life Science industry requires faster product implementation and are subject to regulatory review. For this reason, LuminLogic is designed to comply with FDA 21CFR Part 11 and EU Annex 11 at the time of implementation.

    LuminLogic maintains in a validated state our LuminLogic Hardware / Environment for all clients as part of our best-in-class Software as a Service offering in compliance with FDA 21CFR Part 11 and EU Annex 11.

    Additional optional validation services include:

    • Executed Validation Package that includes:

      • Validation Plan
      • Validation Protocols
      • Validation Report
      • Validation Matrix
    • Customized Validation Packages for your specific Validation needs.

    Validation support can be bundled to include test scripts, documentation, training, configuration and assistance in execution.

    SERVICES
    Implementation
    Compliance is within your Reach

    Ready to implement the right document management solution for your company? With both our Smart Enterprise Suite and Smart Solutions, we’ll manage your installation, and perform a Software Installation Qualification (Software IQ) at your request. The Software IQ becomes part of your files, demonstrating that the solution was properly installed to support its intended use.

    We begin the installation process by asking targeted questions to uncover requirements specific to your business. We discuss your operational practices, areas that need improvement and features you’d like. From there, we help you:

    • Determine which solution will be the best fit for your regulated business
    • Plan for data migration and integration
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