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Technology Validation for Medical Devices

Medical device commercialization increasingly incorporates technology solutions subject to FDA review involving standards testing, technology validation and software validation. Regulators are putting added pressure on medical device companies to demonstrate that their technologies perform safely and as intended. Changes in regulations and in the functionality of technology have made it difficult to successfully meet auditors’ demands unless you have a good technology management program. Tap into our SaMD consulting expertise for your medical device standards.

Our experts in technology validation for medical devices will guide you with:

Implementing a technology management program helps your medical device company:

  • Attain regulatory compliance
  • Identify potential risk factors
  • Reduce application development time
  • Improve business efficiency
  • Provide a qualified, third-party analysis of your systems

At MethodSense, our SaMD consulting technology and software experience grew from the development and productization of LuminLogic Smart Enterprise Suite, a SaaS document management solution for regulated businesses. It’s been further refined through building custom applications for our clients and preparing numerous technology products for market authorization. regulated environments. LuminLogic SES delivers 21 CFR Part 11 and Annex 11 compliance efficiently and securely for critical content management and collaboration.

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.

Tap into our expertise for your medical device standards testing management, technology validation and software validation services today.

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