Medical Device Consulting Services About Us Why MethodSense? MethodSense is a unique combination of people, processes and technology–
specifically focused on the medical device and life science markets.
We ensure regulated companies have the processes and tools
to commercialize, sell, and continue selling their products.

Some people might call it regulatory compliance or quality programs–but we call it business fundamentals.

Domestic and international regulations are changing faster than ever. You need to manage the commercialization of your product and grow your business. And one mis-step can have grave implications. But MethodSense has the resources to help improve your people, processes and core valuation.

From 510(k) submissions to IEC 60601-1 tables and Software Development Lifecycle Management to Quality System Management, our life science and FDA Quality and Regulatory 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!

We're your business partner

Our FDA Quality and Regulatory Consultants leave no stone unturned as they solve your immediate need and then turn to ensuring your future success. From the production floor to the board room and beyond—let the MethodSense difference be your competitive advantage.

When you work with MethodSense to address life science compliance and business needs, you benefit from the additional support of LuminLogic Smart Enterprise Suite (SES), a robust Software as a Service application designed specifically as document management software for regulated environments. LuminLogic SES delivers 21 CFR Part 11 and Annex 11 compliance efficiently and securely for critical content management and collaboration. By utilizing LuminLogic in our engagements, you will:

  • Enhance team and departmental collaboration
  • Improve the efficiency of your project and innovation process
  • Mitigate regulatory risks
  • Reduce time to market
  • Access, share and manage critical business information

Our goals are your goals: grow your business with the best people, scalable processes and smart technology.

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